Cardiac resynchronization in chronic heart failure.
William T Abraham, Westby G Fisher, Andrew L Smith...
https://pubmed.ncbi.nlm.nih.gov/12063368Actively Recruiting
Age: 18Years +
All Genders
ID06342492
Conduction System Versus Surgical Left Ventricular Epicardial Pacing for Coronary Sinus Lead Failure
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-28
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- All patients older than 18 years of age
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66211
Actively Recruiting
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Research Team
D
Donita Atkins
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
Optimal CRT Implantation-Where and How To Place the Left-Ventricular Lead?
Christian Butter, Christian Georgi, Martin Stockburger
https://pubmed.ncbi.nlm.nih.gov/34495452Avoiding non-responders to cardiac resynchronization therapy: a practical guide.
Claude Daubert, Nathalie Behar, Raphaël P Martins...
https://pubmed.ncbi.nlm.nih.gov/27371720Complications of Cardiac Resynchronization Therapy: Comparison of Safety Outcomes from Real-world Studies and Clinical Trials.
Naga Venkata K Pothineni, Suhas Gondi, Tharian Cherian...
https://pubmed.ncbi.nlm.nih.gov/36072440Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects.
C Alonso, C Leclercq, F R d'Allonnes...
https://pubmed.ncbi.nlm.nih.gov/11559679An 8-year single-centre experience of cardiac resynchronisation therapy: procedural success, early and late complications, and left ventricular lead performance.
Syed Y Ahsan, Bunny Saberwal, Pier D Lambiase...
https://pubmed.ncbi.nlm.nih.gov/23315159Minimally invasive left ventricular epicardial lead placement: surgical techniques for heart failure resynchronization therapy.
José L Navia, Fernando A Atik, Richard A Grimm...
https://pubmed.ncbi.nlm.nih.gov/15854930Conduction System Pacing for Cardiac Resynchronisation.
Parikshit S Sharma, Pugazhendhi Vijayaraman
https://pubmed.ncbi.nlm.nih.gov/33936744Cardiac 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.
Xueying Chen, Yang Ye, Zhongkai Wang...
https://pubmed.ncbi.nlm.nih.gov/34718539Five-year follow-up of transvenous and epicardial left ventricular leads: experience with more than 1000 leads.
Heiko Burger, Simon Pecha, Samer Hakmi...
https://pubmed.ncbi.nlm.nih.gov/31633187