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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02536118




Registration number
NCT02536118
Ethics application status
Date submitted
17/08/2015
Date registered
31/08/2015
Date last updated
1/02/2024

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

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Micra Transcatheter Pacing System

Patients implanted with Micra System - Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.


Treatment: Devices: Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute complication rate
Timepoint [1] 0 0
30-days
Primary outcome [2] 0 0
Long-term complication free survival
Timepoint [2] 0 0
9 years
Secondary outcome [1] 0 0
Pacing impedance (ohms) and pacing threshold (volts)
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [2] 0 0
Complications stratified by implant type
Timepoint [2] 0 0
Up to 9 years
Secondary outcome [3] 0 0
Estimate Micra System revision rate
Timepoint [3] 0 0
Up to 9 years
Secondary outcome [4] 0 0
Estimate System Longevity
Timepoint [4] 0 0
Up to 9 years
Secondary outcome [5] 0 0
Confirm the rate response operation of the Micra system
Timepoint [5] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient who is, or is expected to 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
3100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
State/province [3] 0 0
Connecticut
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United States of America
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District of Columbia
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United States of America
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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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Indiana
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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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Kansas
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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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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Wisconsin
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Belgium
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Brussel
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Belgium
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Edegem
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Belgium
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Leuven
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Canada
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Ontario
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Canada
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Montréal
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Czechia
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Praha
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Arhus
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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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France
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Annecy
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Bayonne
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Bordeaux
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France
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Brest
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France
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Chambray les tours
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Nantes
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Rennes Cedex 9
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Rouen
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Jena
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Ulm
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Bari
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Eindhoven
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Enschede
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Groningen
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Leiden
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Maastricht
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Nieuwegein
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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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Trondheim
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Poland
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Poznan
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Poland
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Zabrze
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Portugal
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Lisboa
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Saudi Arabia
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Jeddah
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Saudi Arabia
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Riyadh
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Spain
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Barcelona
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Coruña
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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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Vitoria-Gasteiz
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Sweden
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Uppsala
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Switzerland
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Basel
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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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Geneve
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Switzerland
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Lausanne
Country [117] 0 0
Switzerland
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Lugano
Country [118] 0 0
Switzerland
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Zurich
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Birmingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Bristol
Country [121] 0 0
United Kingdom
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Leeds
Country [122] 0 0
United Kingdom
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Leicester
Country [123] 0 0
United Kingdom
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Liverpool
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London
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Manchester
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Middlesbrough
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Nottingham
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Micra Registry Manager
Address 0 0
Medtronic
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 not provided in https://clinicaltrials.gov/study/NCT02536118