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 range18 Years

SexALL

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).

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 range18 Years

SexALL

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