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Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined endo/epicardial approach | Experimental | combining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach |
|
| stepwise approach | Active Comparator | endocardial scar homogenization only at the first VT ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined endo/epicardial approach | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence (Recurrence of any ventricular tachycardia) | Recurrence of any ventricular tachycardia: any appropriate ICD therapy or VT > 30 seconds of duration recorded by ICD interrogations or on clinical event recorded by electrocardiogram with an initial blanking period of 1 week after the ablation procedure | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| procedure success | success: non-inducibility of any sustained monomorphic VT partial success: non-inducibility of clinical VT (inducibility of non-clinical VT excluding polymorphic VT, VT with cycle length < 200ms) | 2 years |
| procedure related (serious) adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid Hendriks, MD | Contact | 0031107032710 | a.a.hendriks@erasmusmc.nl | |
| Tamas Szilil-Torok, MD, PhD | Contact | 031107035018 | t.szilitorok@erasmusmc.nl |
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| stepwise approach |
| Other |
endocardial scar homogenization only at the first VT ablation procedure |
|
major: death, acute myocardial infarction (AMI) / coronary artery damage, major bleeding - type III and V, abdominal bleeding, tamponade > 80cm3, late tamponade, ischemic cerebral event minor: dry right ventricle puncture, drainable hemopericardium, postprocedural precordial pain, phrenic nerve injury, minor bleeding - type II |
| 30 days |
| procedure time, fluoroscopy and radiofrequency time | one day |
| time to recurrence to ventricular arrhythmia | 2 years |
| number of appropriate ICD therapy on follow-up | 2 years |
| number of ventricular arrhythmia related hospitalizations | 2 years |
| free of antiarrhythmic drugs on follow-up | 2 years |
| repeat procedure | 2 years |
| incessant VT or VT storm on follow-up | 2 years |
| mortality | 2 years |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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