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Recruiting NCT06556485

Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure

No phase Interventional Heart Failure Arrhythmia, Ventricular Cardiomyopathy Ischemic Catheter Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Catheter ablation, Medical therapy.
Who it may be relevant to
Registry conditions: Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)

Overview

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.

Interventions

  • Procedure Catheter ablation
    Preventive ablation therapy
  • Drug Medical therapy
    Optimal medical therapy

Primary outcome measures

  • Primary end point [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (4)
  • Secondary end point 1 [Time frame: through study completion, an average of 2 years]
  • Secondary end point 2 [Time frame: through study completion, an average of 2 years]
  • Secondary end point 3 [Time frame: through study completion, an average of 2 years]
  • Secondary end point 4 [Time frame: through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW — Bad Oeynhausen

Identifiers

NCT: NCT06556485 · HDZ-ER_004_CS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗