RecruitingNot ApplicableNCT06556485

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)


Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Enrollment

160 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

  • 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 Criteria12

  • 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

Interventions

PROCEDURECatheter ablation

Preventive ablation therapy

DRUGMedical therapy

Optimal medical therapy


Locations(1)

Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

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NCT06556485


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