CompletedNot Applicable

Evaluation of VDD Leadless Pacing System During Exercise

Belgium42 participantsStarted 2022-04-01

Plain-language 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 Micra MC1AVR01 can be enrolled in the study. Exercise test is part of the standard clinical care practice for this patients population during the first year follow-up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: \- Frail patient unable to perform an exercise test (cycle test).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise

Timeframe: Exercise test is performed during the first year following the Micra implantation

Characterize the AV synchrony percentage provided by the Micra AV during exercise.

Timeframe: Exercise test is performed during the first year following the Micra implantation

Confirm the safety of the Micra AV during exercise

Timeframe: Exercise test is performed during the first year following the Micra implantation

Trial details

NCT IDNCT06094114

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Bradycardia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise

Timeframe: Exercise test is performed during the first year following the Micra implantation

Characterize the AV synchrony percentage provided by the Micra AV during exercise.

Timeframe: Exercise test is performed during the first year following the Micra implantation

Confirm the safety of the Micra AV during exercise

Timeframe: Exercise test is performed during the first year following the Micra implantation