Leadless Pacemakers vs. Left Bundle Area Pacing for Heart Block
(COMPAREPACE Trial)
Trial Summary
What is the purpose of this trial?
This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Leadless Pacemakers vs. Left Bundle Area Pacing for Heart Block?
Research shows that left bundle branch pacing (LBBP) can improve heart function in patients with heart failure and left bundle branch block by enhancing electrical and mechanical synchrony. Additionally, leadless pacing systems like the WiSE-CRT have shown improvements in heart function and symptoms, indicating potential benefits for heart block treatment.12345
Is the use of leadless pacemakers generally safe in humans?
How is the treatment of Leadless Pacemakers and Left Bundle Area Pacing for Heart Block different from other treatments?
This treatment is unique because it uses leadless pacemakers and left bundle area pacing (LBBAP), which are novel methods for pacing the heart without traditional leads (wires). These approaches can offer benefits like reduced risk of infection and potentially allow for same-day discharge, making them different from conventional pacemaker treatments.1251112
Research Team
Dinesh Sharma, MD
Principal Investigator
NCH Healthcare
Eligibility Criteria
This trial is for individuals who require a pacemaker due to heart block and are eligible for the procedure. Specific eligibility details are not provided, but typically participants must meet certain health criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a leadless pacemaker or left bundle area pacing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Leadless Pacemakers
- Left Bundle Area Pacing
Leadless Pacemakers is already approved in United States, European Union for the following indications:
- Symptomatic paroxysmal or permanent high-grade AV block in the presence of atrial fibrillation
- Bradycardia with normal sinus rhythm with only rare episodes of A-V block or sinus arrest
- Chronic atrial fibrillation
- Severe physical disability
- Management of one or more of the following permanent conditions: syncope, pre-syncope, fatigue, disorientation
- Abnormal or slow heart rhythms
Find a Clinic Near You
Who Is Running the Clinical Trial?
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc