Tests catheter ablation of heart scar to prevent dangerous rhythms in heart failure
Tests a catheter procedure to treat heart scar causing dangerous rhythms in heart failure patients.
Plain-language title generated from the registry record
Registry title: Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Key facts
- Where
- Bad Oeynhausen, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06556485, who can take part
Where in Germany
- Clinic for Electrophysiology, Herz- und Diabeteszentrum NRWBad Oeynhausen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heart and Diabetes Center North-Rhine Westfalia
- Trial code
- NCT06556485
- Record updated
- 4 December 2024
- Original description
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.Read full original descriptionShow less
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
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.
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; Listed as "high urgent" for heart transplantation; Cardiac assist device implanted; Uncontrolled hypertension; Requirement for dialysis due to end-stage renal failure; Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age; Untreated hypothyroidism or hyperthyroidism; Mental or physical inability to participate in the study; Planned cardiovascular intervention; Life expectancy ≤ 12 month.