Endo- and Epicardial vs. Endocardial Ablation of Ventricular Tachycardia in Patients With Cardiac Disease

NCT01767220 | Unknown

• 1 other identifier: A 2012-0125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A significant portion of patients with cardiac diseases like coronary artery disease (CAD), dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC) develops ventricular tachycardia (VT). The standard ablation procedure is carried out from endocardial only. In 30% of patients treated this way a successful ablation is not possible. In these cases the scar areas are mostly located in the outer layer of the myocardium. Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle. In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation. This prospective randomized trial compares the standard ablation procedure (endocardial ablation only) with a new strategy. This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial. The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation only. 40 patients will be enrolled. They will be randomized 1:1 in the study arms "strategy 1" which is standard endocardial ablation and "strategy 2" which is endo- and epicardial ablation. At least 12 months are planned for enrollment. The study is closed if the patient last enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12 months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted cardioverter defibrillator) interrogation. Both ablation strategies are well established and conducted with standard equipment. The methodology of this study does not contain any experimental approaches. The standard insurance coverage of the hospital is guaranteed for all enrolled patients.

Conditions

Ventricular Tachycardia

Keywords

ventricular tachycardia; endocardial ablation; epicardial ablation

Outcome Measures

Primary Outcomes (1)

• recurrence of any VT

  Recurrence of any VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: 3, 6 and 12 months after the date of the VT ablation procedure. In case of emergency (e.g. incessant VT, VT storm, resuscitation due to ventricular fibrillation) an additional ICD interrogation is done at admission to hospital.

  up to 12 months after the date of VT ablation

Secondary Outcomes (3)

• percentage of VT substrates which can only be abolished by epicardial ablation

  date of VT ablation - up to 3 to 5 days

• 12 lead ECG features typical for epicardial VT substrates

  date of VT ablation up to 3 to 5 days

• percentage of epicardial VT substrates referred to the underlying cardiac disease

  date of VT ablation - up to 3 to 5 days

Study Arms (2)

Strategy 1- endocardial ablation

ACTIVE COMPARATOR

VT substrate mapping and VT ablation are done only from endocardial.

Procedure: Strategy 1 - endocardial ablation

Strategy 2 - endocardial and epicardial ablation

ACTIVE COMPARATOR

VT substrate mapping and ablation are done from endocardial and epicardial.

Procedure: Strategy 2 - endocardial and epicardial ablation

Interventions

Strategy 1 - endocardial ablation PROCEDURE

VT substrate mapping and VT ablation are done only from endocardial. Therefore the catheters are introduced through the femoral veins/arteries. For mapping and ablation a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.

Strategy 1- endocardial ablation

Strategy 2 - endocardial and epicardial ablation PROCEDURE

VT substrate mapping and VT ablation are done from endocardial and epicardial. Therefore the catheters are introduced through the femoral veins/arteries and into the pericardial space via a pericardial puncture. After endocardial and epicardial mapping, ablation is done from endocardial. In case of an ineffective endocardial ablation and an epicardial substrate an epicardial ablation is done. For mapping and ablation from endo- and epicardial a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.

Strategy 2 - endocardial and epicardial ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• structural heart disease (CAD, DCM, ARVC)
• ICD already implanted
• documented ventricular tachycardia
• patient is able to give informed consent
• VT ablation because of vital indication

You may not qualify if:

• VT without structural cardiac disease
• VT not documented
• patient is not able to give informed consent
• contraindication for pericardial puncture
• mechanical aortic valve
• pacemaker or ICD with an epicardial lead

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University Hospital of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

RECRUITING

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

Study Officials

• Dietmar Baensch, Prof. Dr.

  University Hospital of Rostock, Dept. of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg Lauschke, Dr.

CONTACT

0049-381-494-7797; joerg.lauschke@uni-rostock.de

Dietmar Baensch, Prof. Dr.

CONTACT

0049-381-494-7797; dietmar.baensch@med.uni-rostock.de

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: Prof. Dr. Dietmar Baensch

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 14, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 30, 2014

Record last verified: 2013-01

Locations

DE (1)