Evaluation of VDD Leadless Pacing System During Exercise

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Bradycardia; Pacemaker DDD

Treatments: Device: pacemaker follow-up

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06094114

s65477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

42 participants in 1 patient group

Patients with Micra Av

Description:

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

Treatment:

Device: pacemaker follow-up