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

Ventricular Tachycardia Clinical Trial

— EPILOGUE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02358746
• Other study ID #: NL48168.078.14
• Status: Not yet recruiting
• Phase: N/A
• First received: January 27, 2015
• Last updated: February 6, 2015
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2015
• Source: Erasmus Medical Center
• Contact: Astrid Hendriks, MD
• Phone: 0031107032710
• Email: a.a.hendriks[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Other:
• combined endo/epicardial approach

• stepwise approach
endocardial scar homogenization only at the first VT ablation procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	procedure related (serious) adverse events	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	Yes
Secondary	procedure time, fluoroscopy and radiofrequency time		one day	No
Secondary	time to recurrence to ventricular arrhythmia		2 years	No
Secondary	number of appropriate ICD therapy on follow-up		2 years	No
Secondary	number of ventricular arrhythmia related hospitalizations		2 years	No
Secondary	free of antiarrhythmic drugs on follow-up		2 years	No
Secondary	repeat procedure		2 years	No
Secondary	incessant VT or VT storm on follow-up		2 years	No
Secondary	mortality		2 years	No