Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker Implantation
- Sponsor
- NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Efficacy & Safety
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Dinesh Sharma
MD
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Eligibility Criteria
Inclusion Criteria
- •Planned for:
- •permanent pacemaker implantation for AV node disease (first, second or third degree), OR
- •post-TAVR patient requiring permanent pacemaker implantation
- •Preserved ejection fraction \> 50%
- •Preserved sinus node function
- •Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- •Life expectancy \> 1 year
- •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.
- •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
- •Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
- •Anatomical restriction for either MICRA or transvenous pacing such as
- •Access vein occlusion or thrombosis
- •previous radiation therapy at insertion site
- •inferior vena cava filter
- •Endstage renal disease (ESRD)/on dialysis
- •Dementia (inability to give consent)
- •Moderate to Severe or Severe Tricuspid valve regurgitation
- •Moderate to Severe or Severe Mitral valve regurgitation
- •History of mitral or tricuspid valve surgery
Outcomes
Primary Outcomes
Efficacy & Safety
Time Frame: 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 Outcomes
- Procedure time(from procedure start to procedure end)
- Device longevity(at 12 month follow up)