Clinical trial NCT06094114: Evaluation of VDD Leadless Pacing System During Exercise
Official title: Evaluation of Atrio-ventricular Synchronous Pacing Rate During Exercise Test in Patients With a VDD Leadless Pacing System (Micra AV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Pacemaker DDD
Keywords: leadless pacemaker
Micra
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Medtronics, Inc.
First posted: 2023-10-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously implanted with Micra AV

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 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.

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 ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
2. Characterize the AV synchrony percentage provided by the Micra AV during exercise.
3. Confirm the safety of the Micra AV during exercise

Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. All subjects provide signed and dated consent that he/she is willing and able to comply with the protocol.

Retrospective patients enrollment 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.

Exercise test The Micra AV permits AV synchronous pacing mode up to a maximal sinus rate of 115/min. Exercise test will therefore be performed up to a maximal heart rate of 115/min. The test will be stopped by the patient (depending on his/her ability/symptoms such as: fatigue, dyspnea, leg pain,..) or by the cardiologist if a maximal heart rate of 115 beats per minute is reached.

Eligibility criteria: 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).

Primary outcomes:
measure: 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
measure: 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
measure: Confirm the safety of the Micra AV during exercise
timeFrame: Exercise test is performed during the first year following the Micra implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
Study officials:
affiliation: University Hospitals of Leuven, cardiovascular department
name: Christophe Garweg, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: