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

NCT06556485 | Recruiting

• 1 other identifier: HDZ-ER_004_CS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary end point 1

  through study completion, an average of 2 years

• Secondary end point 2

  through study completion, an average of 2 years

• Secondary end point 3

  through study completion, an average of 2 years

• Secondary end point 4

  through study completion, an average of 2 years

Study Arms (2)

Ablation group

ACTIVE COMPARATOR

Primary prophylactic ablation

Procedure: Catheter ablation

Control group

ACTIVE COMPARATOR

Optimal medical therapy

Drug: Medical therapy

Interventions

Catheter ablation PROCEDURE

Preventive ablation therapy

Also known as: Ablation

Ablation group

Medical therapy DRUG

Optimal medical therapy

Also known as: Medical

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Interventions

Catheter Ablation; Nutrition Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Christian Sohns, MD

CONTACT

49 5731 971327; csohns@hdz-nrw.de

Astrid Kleemeyer

CONTACT

49 5731 971258; akleemeyer@hdz-nrw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 16, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

DE (1)