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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01524276
Registration number
NCT01524276
Ethics application status
Date submitted
30/01/2012
Date registered
1/02/2012
Date last updated
4/06/2024
Titles & IDs
Public title
Product Surveillance Registry
Query!
Scientific title
Medtronic Product Surveillance Registry
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Secondary ID [1]
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0
PSR
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Universal Trial Number (UTN)
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Trial acronym
PSR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Rhythm Disorders
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0
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Urological Disorders
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Neurological Disorders
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Cardiovascular Disorders
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Digestive Disorders
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Intracranial Aneurysm
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0
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Mechanical Circulatory Support
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Respiratory Therapy
0
0
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Aortic, Peripheral Vascular and Venous Disorders
0
0
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Minimally Invasive Surgical Procedures
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0
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Diagnostic Techniques and Procedures
0
0
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Surgical Procedures, Operative
0
0
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Renal Insufficiency
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0
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Neurovascular
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Coronary Artery Disease
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0
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Ear, Nose and Throat Disorder
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0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
0
0
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0
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Other neurological disorders
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Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Cardiovascular
0
0
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0
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Coronary heart disease
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Cardiovascular
0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Effectiveness of Market Released products
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Assessment method [1]
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Timepoint [1]
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Every 6-12 months (Therapy-dependent)
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Eligibility
Key inclusion criteria
- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with an eligible Medtronic product
- Patient within enrollment window relative to therapy initiation or meets criteria for
retrospective enrollment
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient who is, or will be, inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2030
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Actual
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Sample size
Target
100000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Westmead
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Recruitment hospital [2]
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- Chermside
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Recruitment hospital [3]
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- Murdoch
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Recruitment hospital [4]
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- Southport
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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- Chermside
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Recruitment postcode(s) [3]
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- Murdoch
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Recruitment postcode(s) [4]
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- Southport
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Alaska
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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North Carolina
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Ohio
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South Dakota
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Utah
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Wisconsin
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Argentina
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Austria
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Linz
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Aalst
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Belgium
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Edegem
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Gent
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Liege
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Belgium
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Roeselare
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Quebec City
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Canada
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Toronto
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Country [58]
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Sichuan
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China
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Beijing
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Country [60]
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China
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Changsha
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Country [61]
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China
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Dalian
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Country [62]
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China
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State/province [62]
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Fuzhou
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Country [63]
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China
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State/province [63]
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Harbin
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Country [64]
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China
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State/province [64]
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Kunming
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Country [65]
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China
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State/province [65]
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Nanchang
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Country [66]
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China
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State/province [66]
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Shanghai
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Country [67]
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China
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State/province [67]
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Shantou
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Country [68]
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China
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Suzhou
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Country [69]
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China
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Taiyuan
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Country [70]
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China
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Tianjin
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Country [71]
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Colombia
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State/province [71]
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Cartagena
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Country [72]
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Colombia
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State/province [72]
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Medellin
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Country [73]
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Colombia
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State/province [73]
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Pereira
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Colombia
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State/province [74]
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Rionegro
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Country [75]
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Czechia
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State/province [75]
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Praha
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Denmark
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Hellerup
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Denmark
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Hillerød
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Denmark
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Kobenhavn
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Denmark
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Odense
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Finland
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Helsinki
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Finland
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Tampere
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Avignon
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France
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Bayonne
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France
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Bordeaux
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France
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Boulogne-Billancourt
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France
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Brest Cedex
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France
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Caen
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France
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Chambray
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France
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Clermont Ferrand
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France
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Créteil
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France
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Dijon
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France
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La Rochelle
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France
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La Tronche
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France
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Lille Cedex
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France
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Marseille Cedex 5
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France
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Montpellier Cedex 5
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France
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Nantes
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France
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Neuilly-sur-Seine
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France
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Ollioules
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France
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Paris
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France
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Pringy
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France
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Rennes
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France
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Saint-Priest-en-Jarez
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Strasbourg
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France
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Villeurbanne
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Germany
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Aachen
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Germany
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Bad Oeynhausen
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Germany
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Bremen
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Frankfurt am main
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Germany
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Freiburg
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Germany
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Hagen
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Homburg
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Germany
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Jena
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Germany
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Karlsruhe
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Germany
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Köln
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Leipzig
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Germany
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Lübeck
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Germany
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Munster
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Germany
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München
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Germany
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Ulm
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Germany
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Wiesbaden
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Athens
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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India
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Telangana
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India
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Chennai
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India
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New Delhi
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Ireland
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Galway
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Jerusalem
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Israel
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Ramat Gan
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Italy
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Italy
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Ancona
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Italy
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Castrovillari
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Italy
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Lecce
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Italy
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Milano
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Italy
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Palermo
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Italy
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Pavia
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Roma
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0
Rome
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Taranto
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Udine
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Vimercate
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Osaka
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Saitama
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Tachikawa
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Tokyo
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Tottori
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Chiba
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Fukuoka
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Gifu
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Hirosaki
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Hiroshima City
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Hiroshima
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Kagoshima
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Kamakura
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Kawasaki
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Kitakyushu
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Kumamoto
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Kyoto
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Mitaka
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Nagoya
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Niigata
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Okayama
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Sapporo
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Shinagawa-Ku
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Shizuoka
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Suita
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Toyoake
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Urasoe
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Yokohama
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Osaka-sayama
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Gyeongsangnam-do
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Busan
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Changwon
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Cheongju-si
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Daegu
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Daejeon
Query!
Country [187]
0
0
Korea, Republic of
Query!
State/province [187]
0
0
Gangneung
Query!
Country [188]
0
0
Korea, Republic of
Query!
State/province [188]
0
0
Gwangju
Query!
Country [189]
0
0
Korea, Republic of
Query!
State/province [189]
0
0
Gyeonggi-do
Query!
Country [190]
0
0
Korea, Republic of
Query!
State/province [190]
0
0
Incheon
Query!
Country [191]
0
0
Korea, Republic of
Query!
State/province [191]
0
0
Jeonju
Query!
Country [192]
0
0
Korea, Republic of
Query!
State/province [192]
0
0
Seongnam-si
Query!
Country [193]
0
0
Korea, Republic of
Query!
State/province [193]
0
0
Seoul
Query!
Country [194]
0
0
Korea, Republic of
Query!
State/province [194]
0
0
Suwon-si
Query!
Country [195]
0
0
Kuwait
Query!
State/province [195]
0
0
Kuwait
Query!
Country [196]
0
0
Malaysia
Query!
State/province [196]
0
0
Kuala Lumpur
Query!
Country [197]
0
0
Mexico
Query!
State/province [197]
0
0
Ciudad de mexico
Query!
Country [198]
0
0
Netherlands
Query!
State/province [198]
0
0
Eindhoven
Query!
Country [199]
0
0
Netherlands
Query!
State/province [199]
0
0
Enschede
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Groningen
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Heerlen
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Hengelo
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Leiden
Query!
Country [204]
0
0
Netherlands
Query!
State/province [204]
0
0
Maastricht
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Nieuwegein
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Rotterdam
Query!
Country [207]
0
0
New Zealand
Query!
State/province [207]
0
0
Christchurch
Query!
Country [208]
0
0
Norway
Query!
State/province [208]
0
0
Bergen
Query!
Country [209]
0
0
Norway
Query!
State/province [209]
0
0
Oslo
Query!
Country [210]
0
0
Norway
Query!
State/province [210]
0
0
Trondheim
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Poznan
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Warszawa
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Zabrze
Query!
Country [214]
0
0
Portugal
Query!
State/province [214]
0
0
Creixomil
Query!
Country [215]
0
0
Portugal
Query!
State/province [215]
0
0
Lisboa
Query!
Country [216]
0
0
Portugal
Query!
State/province [216]
0
0
Porto
Query!
Country [217]
0
0
Portugal
Query!
State/province [217]
0
0
Santarém
Query!
Country [218]
0
0
Puerto Rico
Query!
State/province [218]
0
0
Aibonito
Query!
Country [219]
0
0
Puerto Rico
Query!
State/province [219]
0
0
Rio Piedras
Query!
Country [220]
0
0
Serbia
Query!
State/province [220]
0
0
Belgrade
Query!
Country [221]
0
0
Slovakia
Query!
State/province [221]
0
0
Bratislava
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
A Coruña
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Barcelona
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Córdoba
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Girona
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Granada
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
L'Hospitalet De Llobregat
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Madrid
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Málaga
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Palma De Mallorca
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Salamanca
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Santa Cruz De Tenerife
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Santiago De Compostela
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Toledo
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Valencia
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Valladolid
Query!
Country [237]
0
0
Sweden
Query!
State/province [237]
0
0
Göteborg
Query!
Country [238]
0
0
Sweden
Query!
State/province [238]
0
0
Lund
Query!
Country [239]
0
0
Sweden
Query!
State/province [239]
0
0
Skövde
Query!
Country [240]
0
0
Switzerland
Query!
State/province [240]
0
0
Basel
Query!
Country [241]
0
0
Switzerland
Query!
State/province [241]
0
0
Bern
Query!
Country [242]
0
0
Switzerland
Query!
State/province [242]
0
0
Fribourg
Query!
Country [243]
0
0
Switzerland
Query!
State/province [243]
0
0
Geneve
Query!
Country [244]
0
0
Switzerland
Query!
State/province [244]
0
0
Lausanne
Query!
Country [245]
0
0
Switzerland
Query!
State/province [245]
0
0
Lugano
Query!
Country [246]
0
0
Switzerland
Query!
State/province [246]
0
0
Morges
Query!
Country [247]
0
0
Switzerland
Query!
State/province [247]
0
0
Zürich
Query!
Country [248]
0
0
United Kingdom
Query!
State/province [248]
0
0
Barnstaple
Query!
Country [249]
0
0
United Kingdom
Query!
State/province [249]
0
0
Birmingham
Query!
Country [250]
0
0
United Kingdom
Query!
State/province [250]
0
0
Blackpool
Query!
Country [251]
0
0
United Kingdom
Query!
State/province [251]
0
0
Bristol
Query!
Country [252]
0
0
United Kingdom
Query!
State/province [252]
0
0
Leeds
Query!
Country [253]
0
0
United Kingdom
Query!
State/province [253]
0
0
Leicester
Query!
Country [254]
0
0
United Kingdom
Query!
State/province [254]
0
0
Liverpool
Query!
Country [255]
0
0
United Kingdom
Query!
State/province [255]
0
0
London
Query!
Country [256]
0
0
United Kingdom
Query!
State/province [256]
0
0
Manchester
Query!
Country [257]
0
0
United Kingdom
Query!
State/province [257]
0
0
Middlesbrough
Query!
Country [258]
0
0
United Kingdom
Query!
State/province [258]
0
0
Newcastle Upon Tyne
Query!
Country [259]
0
0
United Kingdom
Query!
State/province [259]
0
0
Northampton
Query!
Country [260]
0
0
United Kingdom
Query!
State/province [260]
0
0
Nottingham
Query!
Country [261]
0
0
United Kingdom
Query!
State/province [261]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Medtronic
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the Registry is to provide continuing evaluation and periodic reporting of
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01524276
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Medtronic Product Surveillance Registry
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01524276
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