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

Launched by HEART AND DIABETES CENTER NORTH-RHINE WESTFALIA · Aug 13, 2024

Keywords

ClinConnect Summary

The CASTLE-VT clinical trial is studying a treatment called catheter ablation to help prevent dangerous heart rhythms in patients with severe heart failure. This trial specifically looks at individuals with a condition known as ischemic cardiomyopathy, where the heart's ability to pump blood is weakened due to previous heart attacks. Researchers want to see if this treatment can improve patients' chances of survival and their overall quality of life, particularly for those waiting for a heart transplant or a special heart pump called a left ventricular assist device (LVAD).

To be eligible for this trial, participants need to be at least 18 years old and have a weakened heart function (measured by a test called ejection fraction) of 35% or less. They should have severe symptoms of heart failure that limit their physical activity and be candidates for heart transplant. The study will involve around 160 participants who will be monitored for two years to see how well the treatment works. If you or a loved one meet these criteria, participating in this trial could provide access to new treatment options and contribute to important research in heart health.

Gender

ALL

Eligibility criteria

• 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