Evaluation of VDD Leadless Pacing System During Exercise

Study Overview
=================
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: 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.

Official Title
-----------------
Evaluation of Atrio-ventricular Synchronous Pacing Rate During Exercise Test in Patients With a VDD Leadless Pacing System (Micra AV)

Conditions
-----------------
Bradycardia, Pacemaker DDD

Intervention / Treatment
-----------------
* Device: pacemaker follow-up


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Micra Av<br>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. | Device: pacemaker follow-up<br>* Performance of an exercise test in patients previously implanted with Micra AV<br>* Other names: Micra AV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise | Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise | Exercise test is performed during the first year following the Micra implantation | 
| Characterize the AV synchrony percentage provided by the Micra AV during exercise. | Characterize the AV synchrony percentage provided by the Micra AV during exercise. | Exercise test is performed during the first year following the Micra implantation | 
| Confirm the safety of the Micra AV during exercise | Confirm the safety of the Micra AV during exercise confirmed by the absence of (1) pauses exceeding 2 paced cardiac cycles and (2) oversensing induced tachyarrhythmia exceeding 130 bpm. | Exercise test is performed during the first year following the Micra implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leadless pacemaker, Micra