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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02004873




Registration number
NCT02004873
Ethics application status
Date submitted
3/12/2013
Date registered
9/12/2013
Date last updated
17/01/2018

Titles & IDs
Public title
Micra Transcatheter Pacing Study
Scientific title
Micra Transcatheter Pacing Study
Secondary ID [1] 0 0
Micra
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Micra Pacemaker Implant -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Complications
Timepoint [1] 0 0
Implant to 6 Months Post Implant
Primary outcome [2] 0 0
Pacing Capture Threshold
Timepoint [2] 0 0
6 Months Post Implant
Secondary outcome [1] 0 0
Ventricular Capture Management Threshold
Timepoint [1] 0 0
6 Months Post Implant
Secondary outcome [2] 0 0
Rate Response Operation of Micra
Timepoint [2] 0 0
3 Months and 6 Months Post Implant (combined analysis)

Eligibility
Key inclusion criteria
* Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines
* Subjects who are able and willing to undergo the study requirements and are expected to be geographically stable for the duration of the follow-up.
* Subjects who are at least 18 years of age (or older, if required by local law).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm). (Please note: Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm) can now be included in the study. Medtronic notified all sites on July 23, 2014 that the restriction against pacemaker dependent subjects was lifted, following review of the Early Performance Assessment.)
* Subject has an existing or prior pacemaker, ICD or CRT device implant.
* Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
* Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
* Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
* Subjects who are morbidly obese and physician believes telemetry communication of =5 inches (12.7 cm) could not be obtained with programmer head.
* Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
* Subjects who are considered as unable to tolerate an urgent sternotomy
* Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
* Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
* Subjects with a life expectancy of less than 12- months.
* Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Coenrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
* Subjects with exclusion criteria required by local law (e.g. age, breast feeding, etc.).

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
744
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandria Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Iowa
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United States of America
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Michigan
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Minnesota
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United States of America
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Missouri
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United States of America
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Austria
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Linz
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Canada
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Quebec
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China
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Beijing
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Czechia
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Praha
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Denmark
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København
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France
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Bordeaux
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Greece
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Heraklion
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Hungary
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Budapest
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India
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Hyderabad
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India
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New Delhi
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Italy
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Pisa
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Japan
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Osaka
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Japan
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Shinagawa-Ku
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Japan
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Tokyo
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Japan
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Yokohama
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Malaysia
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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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Eindhoven
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Netherlands
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Nieuwegein
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Serbia
State/province [39] 0 0
Belgrade
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South Africa
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Cape Town
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Spain
State/province [41] 0 0
Barcelona
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United Kingdom
State/province [42] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dwight Reynolds
Address 0 0
University of Oklahoma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 are available at https://clinicaltrials.gov/study/NCT02004873