Ischemic Cardiomyopathy, Ventricular Tachycardia
Conditions
Keywords
epicardial catheter ablation
Brief summary
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.
Interventions
OTHERcombined endo/epicardial approach
OTHERstepwise approach
endocardial scar homogenization only at the first VT ablation procedure
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers 2. history of ischemic heart disease 3. ICD carrier or ICD implantation planned after the ablation 4. informed written consent
Exclusion criteria
1. current unstable angina as defined by current european guidelines 2. AMI \< 30 days or in case of incessant VT \< 14 days 3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram) 4. significant coronary stenosis approachable and clinically relevant for intervention 5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI 6. previous pericarditis 7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions 8. previous thoracic radiation therapy 9. contra-indication for general anaesthesia 10. age below 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence (Recurrence of any ventricular tachycardia) | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure related (serious) adverse events | 30 days | 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 |
| 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 | — |
| procedure success | 2 years | 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) |
| 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 | — |
| number of ventricular arrhythmia related hospitalizations | 2 years | — |
Contacts
Primary ContactAstrid Hendriks, MD
Backup ContactTamas Szilil-Torok, MD, PhD
Outcome results
None listed