Evaluation of VDD Leadless Pacing System During Exercise

NCT06094114 | Completed FDA Device

• 1 other identifier: s65477
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia; Pacemaker DDD

Keywords

leadless pacemaker; Micra

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

pacemaker follow-up DEVICE

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

Also known as: Micra AV

Patients with Micra Av

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously implanted with Micra AV

You may qualify if:

• 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.

You may not qualify if:

• \- Frail patient unable to perform an exercise test (cycle test).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Medtronics, Inc.: collaborator

Study Sites (1)

University Hospitals of Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe Garweg, MD,PHD

  University Hospitals of Leuven, cardiovascular department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: October 23, 2023
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 23, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)