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

NCT ID: NCT02358746

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-12-31

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.

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combined endo/epicardial approach

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

Group Type: EXPERIMENTAL

combined endo/epicardial approach

Intervention Type: OTHER

stepwise approach

endocardial scar homogenization only at the first VT ablation procedure

Group Type: ACTIVE_COMPARATOR

stepwise approach

Intervention Type: OTHER

endocardial scar homogenization only at the first VT ablation procedure

Interventions

combined endo/epicardial approach

Intervention Type: OTHER

stepwise approach

endocardial scar homogenization only at the first VT ablation procedure

Intervention Type: OTHER

Other Intervention Names

endo /epicardial catheter ablation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Astrid Hendriks

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Astrid Hendriks, MD

Role: CONTACT

a.a.hendriks@erasmusmc.nl

0031107032710

Tamas Szilil-Torok, MD, PhD

Role: CONTACT

t.szilitorok@erasmusmc.nl

031107035018

Other Identifiers

NL48168.078.14

Identifier Type: -

Identifier Source: org_study_id