Comparing Conduction System Pacing and Surgical Left Ventricular Epicardial Lead Placement
for Patients with Coronary Sinus Lead Failure in Heart Failure with Reduced Ejection Fraction
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-28
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two approaches for patients with heart failure with reduced ejection fraction HFrEF who have experienced coronary sinus CS lead failure after receiving cardiac resynchronization therapy with defibrillator CRT-D. The study evaluates epicardial lead placement through surgery versus conduction system pacing CSP to see which method may be more effective after lead failure. The trial addresses the lack of clear guidelines and direct comparisons between these two alternatives in patients who have not responded fully to conventional biventricular pacing CRT.
Participants include those who had CS lead failure and underwent either transthoracic left ventricular epicardial lead placement or conduction system pacing as lead revision strategies. The study is observational and retrospective, focusing on patients who had lead placement with devices from Medtronic, Boston Scientific, or Abbott. The two groups being compared are those receiving CSP and those receiving epicardial lead placement, with data collected from past procedures.
During the study, researchers review patient records to assess outcomes like the need for further lead revision on the day of the procedure and electrocardiography characteristics, specifically the QRS interval. This observational approach collects data without administering new treatments. The study began in November 2023 and aims to complete data collection by December 2024. Participants are adults aged 18 and older who have experienced lead failure after CRT-D implantation.
CONDITIONS
Brief Title
Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Research Team
D
Donita Atkins
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Patients with heart failure with reduced ejection fraction (HFrEF) who underwent biventricular pacing cardiac resynchronization therapy (BVP-CRT)
Experienced coronary sinus lead failure, initial or recurrent, replaced with either transthoracic epicardial lead placement or conduction system pacing (CSP)
Underwent lead placement using Medtronic, Boston Scientific, or Abbott devices
You will not qualify if you...
Patients younger than 18 years of age
Epicardial lead placement or conduction system pacing performed as the initial approach or for reasons other than lead replacement
Patients for whom cardiac resynchronization therapy no longer provides symptom relief or mortality benefit
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants undergo lead placement using either conduction system pacing or transthoracic epicardial lead placement approaches to address coronary sinus lead failure.
1 procedure visit
Long-term Monitoring
Duration - Up to study completion in December 2024
Participants are observed for outcomes such as the need for lead revision and electrocardiography changes following lead placement.
Follow-up visits as scheduled during study period
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
An 8-year single-centre experience of cardiac resynchronisation therapy: procedural success, early and late complications, and left ventricular lead performance.
Cardiac resynchronization therapy via left bundle branch pacing vs. optimized biventricular pacing with adaptive algorithm in heart failure with left bundle branch block: a prospective, multi-centre, observational study.
Rescue left bundle branch area pacing in coronary venous lead failure or nonresponse to biventricular pacing: Results from International LBBAP Collaborative Study Group.
Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing.