Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach (EPILOGUE)

Erasmus University

Status: Unknown

Conditions: Ischemic Cardiomyopathy; Ventricular Tachycardia

Treatments: Other: stepwise approach; Other: combined endo/epicardial approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02358746

NL48168.078.14

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

combined endo/epicardial approach

Experimental group

Description:

combining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach

Treatment:

Other: combined endo/epicardial approach

stepwise approach

Active Comparator group

Description:

endocardial scar homogenization only at the first VT ablation procedure

Treatment:

Other: stepwise approach