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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Transplantation; Left Ventricular Assist Device; Catheter Ablation; Arrhythmia, Ventricular; Cardiomyopathy Ischemic
• Intervention / Treatment: Procedure: Catheter ablation; Drug: Medical therapy

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Astrid Kleemeyer; Phone Number: 49 5731 971258; Email: akleemeyer@hdz-nrw.de
• Study Contact Backup: Name: Christian Sohns, MD; Phone Number: 49 5731 971327; Email: csohns@hdz-nrw.de

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Recruiting
    • Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
    • Contact: Astrid Kleemeyer; Phone Number: 0495731971258; Email: akleemeyer@hdz-nrw.de
    • Principal Investigator: Christian Sohns, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
2. Eligible for heart transplantation due to end-stage heart failure
3. NYHA class ≥ III
4. Impaired functional capacity or inability to exercise
5. Indication for ICD therapy due to primary prevention
6. Implanted ICD or ICD implantation within 3 months after randomization
7. The patient is willing and able to comply with the protocol and has provided written informed consent
8. Age ≥ 18 years

Exclusion Criteria:

1. Previous catheter ablation for ventricular arrhythmias
2. Previous appropriate ICD-therapy for ventricular arrhythmias
3. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
4. Untreated hypothyroidism or hyperthyroidism
5. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
6. Mental or physical inability to participate in the study
7. Listed as "high urgent" for heart transplantation
8. Cardiac assist device implanted
9. Planned cardiovascular intervention
10. Life expectancy ≤ 12 month
11. Uncontrolled hypertension
12. Requirement for dialysis due to end-stage renal failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ablation group; Primary prophylactic ablation	Procedure: Catheter ablation; Preventive ablation therapy; Other Names: Ablation
Active Comparator: Control group; Optimal medical therapy	Drug: Medical therapy; Optimal medical therapy; Other Names: Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary end point	Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary end point 1	all-cause mortality, cardiovascular mortality	through study completion, an average of 2 years
Secondary end point 2	incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes	through study completion, an average of 2 years
Secondary end point 3	Quality of life, time to first ICD therapy	through study completion, an average of 2 years
Secondary end point 4	LV function, exercise tolerance	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Failure; Cardiomyopathies; Arrhythmias, Cardiac
• Other Study ID Numbers: HDZ-ER_004_CS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No