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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00271180
Registration number
NCT00271180
Ethics application status
Date submitted
28/12/2005
Date registered
30/12/2005
Date last updated
16/08/2024
Titles & IDs
Public title
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
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Scientific title
Medtronic CRDM Product Performance Report
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Secondary ID [1]
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0
602
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Universal Trial Number (UTN)
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Trial acronym
PPR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arrhythmia
0
0
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Bradycardia
0
0
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Heart Failure
0
0
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Sinus Tachycardia
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Cardiovascular
0
0
0
0
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Normal development and function of the cardiovascular system
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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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Lead related complications for each lead model.
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Assessment method [1]
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All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.
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Timepoint [1]
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Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).
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Eligibility
Key inclusion criteria
Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
• Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB
AND one of the following must also apply:
* Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
* Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
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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
* Subjects who are, or will be inaccessible for follow-up
* Subjects with exclusion criteria required by local law (EMEA only)
* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
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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
1/01/1983
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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
1/12/2040
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Actual
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Sample size
Target
20000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Chermside
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Recruitment hospital [2]
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- Douglas
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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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- Chermside
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Recruitment postcode(s) [2]
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- Douglas
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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
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Country [152]
0
0
Japan
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State/province [152]
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0
Urasoe
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Japan
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State/province [153]
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Yamagata
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Country [154]
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Japan
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State/province [154]
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Yokohama
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Country [155]
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Japan
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Osaka-sayama
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Korea, Republic of
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Cheongju-si
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Country [157]
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gyeonggi-do
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Country [159]
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Korea, Republic of
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Seoul
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Country [160]
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Korea, Republic of
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Suwon-si
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Country [161]
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Kuwait
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State/province [161]
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Hadiya
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Country [162]
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Kuwait
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State/province [162]
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Kuwait
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Country [163]
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Malaysia
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State/province [163]
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Kuala Lumpur
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Den Haag
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Netherlands
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Eindhoven
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Netherlands
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State/province [168]
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Enschede
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Netherlands
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Groningen
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Netherlands
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Leiden
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Poznan
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Poland
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Warsaw
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Poland
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Zabrze
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Portugal
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Carnaxide
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Portugal
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State/province [182]
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Creixomil
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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State/province [185]
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Santarém
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Saudi Arabia
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State/province [186]
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Jeddah
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Saudi Arabia
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State/province [187]
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Riyadh
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Serbia
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State/province [188]
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Belgrade
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Slovakia
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Bratislava
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Slovakia
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State/province [190]
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Košice
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Slovenia
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State/province [191]
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Ljubljana
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Spain
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State/province [192]
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A Coruña
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Girona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Palma De Mallorca
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Spain
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Salamanca
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Spain
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Santa Cruz De Tenerife
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Spain
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Santiago de Compostela
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Spain
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Toledo
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Vitoria-Gasteiz
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Sweden
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State/province [206]
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Göteborg
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Country [207]
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Sweden
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Lund
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Country [208]
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Sweden
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Skövde
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Country [209]
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Sweden
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Uppsala
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Country [210]
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Switzerland
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Basel
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Country [211]
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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Geneva
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Switzerland
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Zürich
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United Kingdom
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Birmingham
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Country [218]
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United Kingdom
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Blackpool
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United Kingdom
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Bristol
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United Kingdom
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Leeds
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Country [221]
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United Kingdom
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Leicester
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Country [222]
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United Kingdom
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Liverpool
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Country [223]
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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United Kingdom
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Northampton
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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Country [229]
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00271180
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Product Performance Report Study Leader
Query!
Address
0
0
Medtronic
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Medtronic CRM Clinical Trials
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00271180
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