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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation group | Active Comparator | Primary prophylactic ablation |
|
| Control group | Active Comparator | Optimal medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Preventive ablation therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Sohns, MD | Contact | 49 5731 971327 | csohns@hdz-nrw.de | |
| Astrid Kleemeyer | Contact | 49 5731 971258 | akleemeyer@hdz-nrw.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW | Recruiting | Bad Oeynhausen | 32545 | Germany |
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| Medical therapy | Drug | Optimal medical therapy |
|
|
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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