NCT06556485Recruiting
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 17 Jul 2024
- Start date
- 13 Sept 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Diseases
- Heart failure
- NCT number
- NCT06556485
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 13 Sept 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Listed as "high urgent" for heart transplantation
- Cardiac assist device implanted
- Uncontrolled hypertension
- Requirement for dialysis due to end-stage renal failure
Age
- Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
Other
- Untreated hypothyroidism or hyperthyroidism
- Mental or physical inability to participate in the study
- Planned cardiovascular intervention
- Life expectancy ≤ 12 month
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.