Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure

Not Applicable

Recruiting

• Conditions: Heart Failure; Arrhythmia, Ventricular; Heart Transplantation; Cardiomyopathy Ischemic; Catheter Ablation; Left Ventricular Assist Device
• Interventions: Procedure: Catheter ablation; Drug: Medical therapy

• Registration Number: NCT06556485
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Study Start: 2024-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-06-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation group	Catheter ablation	Primary prophylactic ablation
Control group	Medical therapy	Optimal medical therapy

Primary Outcome Measures

Name	Time	Method
Primary end point	through study completion, an average of 2 years	Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation

Secondary Outcome Measures

Name	Time	Method
Secondary end point 3	through study completion, an average of 2 years	Quality of life, time to first ICD therapy
Secondary end point 1	through study completion, an average of 2 years	all-cause mortality, cardiovascular mortality
Secondary end point 2	through study completion, an average of 2 years	incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes
Secondary end point 4	through study completion, an average of 2 years	LV function, exercise tolerance

Trial Locations

Locations (1)

Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany