75 Participants Needed

Leadless Pacemakers vs. Left Bundle Area Pacing for Heart Block

(COMPAREPACE Trial)

DS
KB
Overseen ByKathy Byrd, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Leadless pacemakers like the Micra and Aveir have been shown to be generally safe, but there can be complications such as cardiac tamponade (fluid buildup around the heart) and rare cases of heart rhythm problems. Overall, they are considered a safe alternative to traditional pacemakers.678910

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 | NCH Provider Directory

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

Life expectancy > 1 year
Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB
See 5 more

Exclusion Criteria

Sinus node dysfunction, anticipating atrial pacing or atrial fibrillation
I have had surgery on my heart valves.
I am able to understand and give consent for my treatment.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a leadless pacemaker or left bundle area pacing

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Leadless Pacemakers
  • Left Bundle Area Pacing
Trial Overview The study compares two types of pacemakers: leadless pacemakers versus left bundle area pacing. It's a randomized controlled trial, meaning patients are randomly assigned to one of the two groups in equal numbers.
Participant Groups
2Treatment groups
Active Control
Group I: Left bundle area pacingActive Control1 Intervention
Transvenous pacemaker with left bundle area pacing
Group II: MICRA AVActive Control1 Intervention
Transcatheter pacemaker with MICRA AV

Leadless Pacemakers is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Micra Transcatheter Pacing System for:
  • Symptomatic paroxysmal or permanent high-grade AV block in the presence of atrial fibrillation
🇺🇸
Approved in United States as Aveir VR Leadless Pacemaker for:
  • Bradycardia with normal sinus rhythm with only rare episodes of A-V block or sinus arrest
  • Chronic atrial fibrillation
  • Severe physical disability
🇺🇸
Approved in United States as Aveir DR Leadless Pacemaker System for:
  • Management of one or more of the following permanent conditions: syncope, pre-syncope, fatigue, disorientation
🇪🇺
Approved in European Union as Aveir DR Leadless Pacemaker System for:
  • 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

Trials
2
Recruited
240+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

In a study of 83 patients undergoing left bundle branch area pacing (LBBP), both stylet-driven and lumenless lead delivery systems achieved similar success rates (77% overall), indicating that both methods are effective for this procedure.
The stylet-driven lead delivery system resulted in significantly shorter procedure and fluoroscopy times compared to the lumenless system, suggesting it may be more efficient while maintaining comparable safety and efficacy.
Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing.Braunstein, ED., Kagan, RD., Olshan, DS., et al.[2023]
The WiSE-CRT system successfully demonstrated the technical feasibility of leadless left bundle branch area pacing (LBBAP) in two patients, showing effective electrical resynchronization and hemodynamic response, which is crucial for treating heart conditions like complete heart block.
Leadless CRT offers a promising alternative for patients with complications from traditional leads, potentially improving treatment options for those with venous access issues, although further studies are needed to evaluate its long-term safety and efficacy.
Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series.Elliott, MK., Jacon, P., Sidhu, BS., et al.[2022]
Left bundle branch area pacing (LBBAP) is a safe and effective method for patients requiring ventricular pacing, showing no complications during implantation and stable pacing parameters over an average follow-up of 9.2 months.
Patients receiving LBBAP exhibited a right bundle branch block (RBBB) morphology on ECG with significantly shorter QRS duration and stimulus to peak left ventricular activation time compared to those paced at the right ventricular septum, indicating improved electrical activation of the heart.
The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block.Chen, TP., Shi, XJ., Lu, DY., et al.[2021]

References

Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing. [2023]
Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series. [2022]
The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block. [2021]
Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. [2022]
Contrast-enhanced image-guided lead deployment for left bundle branch pacing. [2022]
Aveir Leadless Pacemaker: Novel Technology With New Anesthetic Implications. [2023]
Implant efficiency and clinical performance of Aveir™ VR and Micra™ VR leadless pacemaker: A multicenter comparative analysis of 67 patients. [2023]
Leadless pacemaker use in a patient with a durable left ventricular assist device. [2021]
Atrio-ventricular synchronous pacing with a single chamber leadless pacemaker: Programming and trouble shooting for common clinical scenarios. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Ventricular Fibrillation Cardiopulmonary Arrest Following Micra™ Leadless Pacemaker Implantation. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Same-Day Discharge After Left Bundle Area Pacing. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. [2023]
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