Comparing two methods for pacing after lead failure in heart failure patients
Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
This study is testing whether two different methods of pacing can help heart failure patients who have had problems with their heart leads feel better and stay safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation Academic / other |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06342492 on ClinicalTrials.gov |
What this trial studies
This observational study examines patients with heart failure and reduced ejection fraction who have experienced coronary sinus lead failure after undergoing biventricular pacing. It compares the outcomes of transthoracic epicardial lead placement versus coronary sinus pacing as alternatives for lead revision. The study aims to provide insights into the effectiveness and safety of these two approaches, addressing the lack of head-to-head data in this patient population. By analyzing patient outcomes, the research seeks to inform clinical decision-making for those facing lead-related complications.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with heart failure and reduced ejection fraction who have experienced coronary sinus lead failure after biventricular pacing.
Not a fit: Patients who are younger than 18 or those for whom cardiac resynchronization therapy no longer provides symptom relief or mortality benefit may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective pacing method for patients with lead failure, potentially improving their quality of life and clinical outcomes.
How similar studies have performed: While there is limited head-to-head data comparing these two approaches, previous studies have shown that both epicardial lead placement and coronary sinus pacing can be viable alternatives in patients with lead failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients older than 18 years of age * Patients with HFrEF that underwent BVP-CRT * Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP * Underwent Medtronic, Boston Scientific, or Abbott lead placement Exclusion Criteria: * Patients younger than 18 years of age * Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement * Those for which CRT no longer provides symptom relief or mortality benefit.
Where this trial is running
Overland Park, Kansas
- Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Naga Venkata K. Pothineni — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.