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

NCT06556485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Heart Failure
  • Arrhythmia, Ventricular
  • Cardiomyopathy Ischemic
  • Catheter Ablation
  • Heart Transplantation
  • Left Ventricular Assist Device

Interventions

PROCEDURE

Catheter ablation

Preventive ablation therapy

DRUG

Medical therapy

Optimal medical therapy

Sponsors & Collaborators

  • Heart and Diabetes Center North-Rhine Westfalia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2026-06-01
Completion
2027-01-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556485 on ClinicalTrials.gov