Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

Not Applicable

Recruiting

• Conditions: Pacemaker Implantation; AV Node Disease

• Registration Number: NCT06690333
• Lead Sponsor: NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Brief Summary

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.

Detailed Description

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. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.

Study Timeline

• Study Start: 2024-11-05
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Age > 18
2. Planned for permanent pacemaker implantation for AV node disease (first, second or third degree)
3. Preserved ejection fraction > 50%
4. Preserved sinus node function
5. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
6. Life expectancy > 1 year
7. Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth control, vasectomized partner, sexual abstinence, etc.) during the course of the study.
8. Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB

Exclusion Criteria

1. Sinus node dysfunction, anticipating atrial pacing or atrial fibrillation

2. Anatomical restriction for either MICRA or transvenous pacing such as

   1. Access vein occlusion or thrombosis
   2. previous radiation therapy at insertion site
   3. inferior vena cava filter

3. Endstage renal disease (ESRD)/on dialysis

4. Dementia (inability to give consent)

5. Moderate to Severe Tricuspid valve regurgitation

6. Moderate to Severe Mitral valve regurgitation

7. History of mitral or tricuspid valve surgery

8. Preexisting implanted pacemaker or ICD or lead

9. Subject is allergic to titanium

10. Life expectancy < 1 year

11. Recurrent or high risk of infections

12. Active malignancy requiring systemic chemotherapy or local chest radiation

13. Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit

14. CABG, valve surgery or PCI within the last 3 months

15. Other major cardiac surgery within the last 6 months

16. Persistent and permanent atrial fibrillation diagnosed by a healthcare provider

17. NYHA class 3 or 4 Heart Failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy & Safety	12 months	The composite of: 1. procedural success; 2. freedom from serious device-related complications at one year; 3. freedom from heart failure or drop in ejection fraction below 50%.

Secondary Outcome Measures

Name	Time	Method
Procedure time	from procedure start to procedure end	measured in minutes
Device longevity	at 12 month follow up	device longevity as noted on interrogation reports

Trial Locations

Locations (1)

NCH Healthcare; 🇺🇸 Naples, Florida, United States