NCT06556485 Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
| NCT ID | NCT06556485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-09-13 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06556485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06556485 currently recruiting?
Yes, NCT06556485 is actively recruiting participants. Contact the research team at csohns@hdz-nrw.de for enrollment information.
Where is the NCT06556485 trial being conducted?
This trial is being conducted at Bad Oeynhausen, Germany.
Who is sponsoring the NCT06556485 clinical trial?
NCT06556485 is sponsored by Heart and Diabetes Center North-Rhine Westfalia. The trial plans to enroll 160 participants.
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