Status:
RECRUITING
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Lead Sponsor:
Heart and Diabetes Center North-Rhine Westfalia
Conditions:
Heart Failure
Arrhythmia, Ventricular
Eligibility:
All Genders
18-99 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
- Eligible for heart transplantation due to end-stage heart failure
- NYHA class ≥ III
- Impaired functional capacity or inability to exercise
- Indication for ICD therapy due to primary prevention
- Implanted ICD or ICD implantation within 3 months after randomization
- The patient is willing and able to comply with the protocol and has provided written informed consent
- Age ≥ 18 years
Exclusion
- Previous catheter ablation for ventricular arrhythmias
- Previous appropriate ICD-therapy for ventricular arrhythmias
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
- Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
- Mental or physical inability to participate in the study
- Listed as "high urgent" for heart transplantation
- Cardiac assist device implanted
- Planned cardiovascular intervention
- Life expectancy ≤ 12 month
- Uncontrolled hypertension
- Requirement for dialysis due to end-stage renal failure
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06556485
Start Date
September 13 2024
End Date
January 1 2027
Last Update
December 4 2024
Active Locations (1)
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1
Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545