Evaluation of VDD Leadless Pacing System During Exercise

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT06094114

Collaborator

Medtronics, Inc. (Industry)

Enrollment

Location

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bradycardia Pacemaker DDD	Device: pacemaker 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.

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with Micra Av 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 Performance of an exercise test in patients previously implanted with Micra AV Other Names: Micra AV

Arm

Intervention/Treatment

Patients with Micra Av

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

Performance of an exercise test in patients previously implanted with Micra AV

Other Names:

Micra AV

Outcome Measures

Primary Outcome Measures

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 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. [Exercise test is performed during the first year following the Micra implantation]
Characterize the AV synchrony percentage provided by the Micra AV during exercise.
Confirm the safety of 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 confirmed by the absence of (1) pauses exceeding 2 paced cardiac cycles and (2) oversensing induced tachyarrhythmia exceeding 130 bpm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven
Medtronics, Inc.

Investigators

Principal Investigator: Christophe Garweg, MD,PHD, University Hospitals of Leuven, cardiovascular department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov Identifier:

NCT06094114

Other Study ID Numbers:

s65477

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Universitaire Ziekenhuizen KU Leuven

leadless pacemaker

Micra

Additional relevant MeSH terms:

Bradycardia

Study Results

No Results Posted as of Oct 23, 2023