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

NCT02358746 | Unknown DMC

• 1 other identifier: NL48168.078.14
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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

Keywords

epicardial catheter ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• procedure success

  2 years

• procedure related (serious) adverse events

  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

Study Arms (2)

combined endo/epicardial approach

EXPERIMENTAL

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

Other: combined endo/epicardial approach

stepwise approach

ACTIVE COMPARATOR

endocardial scar homogenization only at the first VT ablation procedure

Other: stepwise approach

Interventions

combined endo/epicardial approach OTHER

Also known as: endo /epicardial catheter ablation

combined endo/epicardial approach

stepwise approach OTHER

endocardial scar homogenization only at the first VT ablation procedure

stepwise approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
• history of ischemic heart disease
• ICD carrier or ICD implantation planned after the ablation
• informed written consent

You may not qualify if:

• current unstable angina as defined by current european guidelines
• AMI \< 30 days or in case of incessant VT \< 14 days
• absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
• significant coronary stenosis approachable and clinically relevant for intervention
• presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
• previous pericarditis
• presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
• previous thoracic radiation therapy
• contra-indication for general anaesthesia
• age below 18 years

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Astrid Hendriks, MD

CONTACT

0031107032710; a.a.hendriks@erasmusmc.nl

Tamas Szilil-Torok, MD, PhD

CONTACT

031107035018; t.szilitorok@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 9, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 9, 2015

Record last verified: 2015-02