Evaluation of VDD Leadless Pacing System During Exercise

The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise:

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

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).