Actively Recruiting
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Led by Heart and Diabetes Center North-Rhine Westfalia · Updated on 2024-12-04
160
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ischemic cardiomyopathy with left ventricular ejection fraction 35% measured within 6 weeks before enrollment
- Eligible for heart transplantation due to end-stage heart failure
- New York Heart Association (NYHA) class 3 or higher
- Impaired ability to exercise or inability to exercise
- Indication for implantable cardioverter-defibrillator (ICD) therapy for primary prevention
- Implanted ICD or planned ICD implantation within 3 months after randomization
- Willingness and ability to comply with the study protocol and provide written informed consent
- Age 18 years or older
You will not qualify if you...
- Previous catheter ablation for ventricular arrhythmias
- Previous appropriate ICD therapy for ventricular arrhythmias
- Acute coronary syndrome, cardiac surgery, angioplasty, or stroke within 4 weeks before enrollment
- Untreated hypothyroidism or hyperthyroidism
- Pregnant, breastfeeding, or not using reliable contraception 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 of 12 months or less
- Uncontrolled high blood pressure
- Need for dialysis due to end-stage kidney failure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Actively Recruiting
Research Team
C
Christian Sohns, MD
CONTACT
A
Astrid Kleemeyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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