Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation, Heart Failure, Heart Transplantation, Left Ventricular Assist Device
Conditions
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.
Interventions
PROCEDURECatheter ablation
Preventive ablation therapy
DRUGMedical therapy
Optimal medical therapy
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary end point | through study completion, an average of 2 years | Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary end point 1 | through study completion, an average of 2 years | all-cause mortality, cardiovascular mortality |
| Secondary end point 2 | 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 |
| Secondary end point 3 | through study completion, an average of 2 years | Quality of life, time to first ICD therapy |
| Secondary end point 4 | through study completion, an average of 2 years | LV function, exercise tolerance |
Countries
Germany
Contacts
Primary ContactChristian Sohns, MD
Backup ContactAstrid Kleemeyer
Outcome results
None listed