Status:
COMPLETED
Evaluation of VDD Leadless Pacing System During Exercise
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Medtronics, Inc.
Conditions:
Bradycardia
Pacemaker DDD
Eligibility:
All Genders
18+ years
Brief Summary
The study is a non-randomized, active prospective observational study permitting to report the behavior of Micra AV pacemaker during an exercise. Only patients who were previously implanted with a Mi...
Detailed Description
The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise: 1. Characterize the atrial detection rate/A4 amplitude by a ventricu...
Eligibility Criteria
Inclusion
- Patients previously implanted with a Micra MC1AVR01
- Signed and dated consent (patient confirms that he/she is willing and able to comply with the protocol)
- Patient is physically able to perform an exercise test (cycle test).
- Retrospective patients enrolment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.
- Co-enrolment in the Micra AV post-approvals study is allowed.
Exclusion
- \- Frail patient unable to perform an exercise test (cycle test).
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06094114
Start Date
April 1 2022
End Date
December 31 2022
Last Update
October 23 2023
Active Locations (1)
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1
University Hospitals of Leuven
Leuven, Belgium, 3000