Evaluation of VDD Leadless Pacing System During Exercise

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094114
• Other study ID #: s65477
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bradycardia
• Pacemaker DDD

Intervention

Device:
• pacemaker follow-up
Performance of an exercise test in patients previously implanted with Micra AV

Locations

Country	Name	City	State
Belgium	University Hospitals of Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Medtronics, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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