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NCT Number: NCT06556485

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

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.

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Key information

Conditions

Heart Failure Arrhythmia, Ventricular Arrhythmias, Cardiac Cardiomyopathy Ischemic Cardiovascular Diseases Catheter Ablation Heart Diseases Heart Transplantation Left Ventricular Assist Device Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location status: Recruiting

Location contact

Astrid Kleemeyer

CONTACT

[email protected]

0495731971258

Christian Sohns, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter ablation

Procedure

Preventive ablation therapy

Other names: Ablation

Medical Therapy

Drug

Optimal medical therapy

Other names: Medical

Primary outcomes

  1. Primary end point

    Time frame: through study completion, an average of 2 years

    Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation

Secondary outcomes

  1. Secondary end point 1

    Time frame: through study completion, an average of 2 years

    all-cause mortality, cardiovascular mortality

  2. Secondary end point 2

    Time frame: through study completion, an average of 2 years

    incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes

  3. Secondary end point 3

    Time frame: through study completion, an average of 2 years

    Quality of life, time to first ICD therapy

  4. Secondary end point 4

    Time frame: through study completion, an average of 2 years

    LV function, exercise tolerance

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Kleemeyer

CONTACT

[email protected]

49 5731 971258

Christian Sohns, MD

CONTACT

[email protected]

49 5731 971327

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

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

Acronym: CASTLE-VT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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