Preventive catheter ablation for heart failure patients with ventricular arrhythmias
Official title: Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
Run by Heart and Diabetes Center North-Rhine Westfalia · NCT06556485 · Data updated 2026-11-12
This study is testing if a heart procedure called catheter ablation can help heart failure patients with irregular heartbeats live longer and feel better compared to standard treatment before they get a heart transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia Academic / other |
| Locations | 1 site (Bad Oeynhausen) |
| Status | Recruiting |
| Started | September 13, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT06556485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with ischemic cardiomyopathy, left ventricular ejection fraction of 35% or less, and classified as NYHA class III or higher.
✕Probably not a fit
Patients who have previously undergone catheter ablation for ventricular arrhythmias or have had recent acute coronary events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of prophylactic catheter ablation in patients with ischemic cardiomyopathy who are being considered for heart transplantation. The study employs a substrate-based approach to map and ablate myocardial scars while the heart is predominantly in sinus rhythm. It aims to assess the impact of this intervention on all-cause mortality, worsening heart failure, and other secondary endpoints over a follow-up period of two years. A total of 160 patients will be randomized to receive either the ablation treatment or standard medical therapy.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and improve quality of life for patients with end-stage heart failure and ventricular arrhythmias.
How similar studies have gone: Other studies have shown promise with similar catheter ablation approaches in managing ventricular arrhythmias, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment) 2. Eligible for heart transplantation due to end-stage heart failure 3. NYHA class ≥ III 4. Impaired functional capacity or inability to exercise 5. Indication for ICD therapy due to primary prevention 6. Implanted ICD or ICD implantation within 3 months after randomization 7. The patient is willing and able to comply with the protocol and has provided written informed consent 8. Age ≥ 18 years Exclusion Criteria: 1. Previous catheter ablation for ventricular arrhythmias 2. Previous appropriate ICD-therapy for ventricular arrhythmias 3. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment 4. Untreated hypothyroidism or hyperthyroidism 5. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age 6. Mental or physical inability to participate in the study 7. Listed as "high urgent" for heart transplantation 8. Cardiac assist device implanted 9. Planned cardiovascular intervention 10. Life expectancy ≤ 12 month 11. Uncontrolled hypertension 12. Requirement for dialysis due to end-stage renal failure
Where it's running
-
Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany Recruiting
Study contacts
- Study coordinator: Christian Sohns, MD
- Email: csohns@hdz-nrw.de
- Phone: 49 5731 971327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.