NCT06094114

Evaluation of VDD Leadless Pacing System During Exercise

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Bradycardia
• Pacemaker DDD

Interventions

Type	Name	Description
DEVICE	pacemaker follow-up	Performance of an exercise test in patients previously implanted with Micra AV

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study