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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Rostock
Sponsor:
Information provided by (Responsible Party):
Dietmar Baensch, University of Rostock
ClinicalTrials.gov Identifier:
NCT01767220
First received: January 7, 2013
Last updated: January 29, 2014
Last verified: January 2013
  Purpose

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.


Condition Intervention
Ventricular Tachycardia
Procedure: Strategy 1 - endocardial ablation
Procedure: Strategy 2 - endocardial and epicardial ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Endo- and Epicardial vs. Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease (VTeee)

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • recurrence of any VT [ Time Frame: up to 12 months after the date of VT ablation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • percentage of VT substrates which can only be abolished by epicardial ablation [ Time Frame: date of VT ablation - up to 3 to 5 days ] [ Designated as safety issue: No ]
    This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.

  • 12 lead ECG features typical for epicardial VT substrates [ Time Frame: date of VT ablation up to 3 to 5 days ] [ Designated as safety issue: No ]
    This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.

  • percentage of epicardial VT substrates referred to the underlying cardiac disease [ Time Frame: date of VT ablation - up to 3 to 5 days ] [ Designated as safety issue: No ]
    This secondary outcome measure is evaluated only once during the hospital stay at the date of the VT ablation procedure. The average time of hospital stay for VT ablation is estimated to 3 to 5 days.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strategy 1- endocardial ablation
VT substrate mapping and VT ablation are done only from endocardial.
Procedure: Strategy 1 - endocardial ablation
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.
Active Comparator: Strategy 2 - endocardial and epicardial ablation
VT substrate mapping and ablation are done from endocardial and epicardial.
Procedure: Strategy 2 - endocardial and epicardial ablation
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767220

Contacts
Contact: Joerg Lauschke, Dr. 0049-381-494-7797 joerg.lauschke@uni-rostock.de
Contact: Dietmar Baensch, Prof. Dr. 0049-381-494-7797 dietmar.baensch@med.uni-rostock.de

Locations
Germany
University Hospital of Rostock Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Contact: Joerg Lauschke, Dr. med.    0049-381-494-7797    joerg.lauschke@uni-rostock.de   
Principal Investigator: Dietmar Baensch, Prof. Dr.         
Sub-Investigator: Ralph Schneider, Dr.         
Sub-Investigator: Joerg Lauschke, Dr.         
Sub-Investigator: Wolfgang Voss, Dr.         
Sub-Investigator: Imke Wendig, Dr.         
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Dietmar Baensch, Prof. Dr. University Hospital of Rostock, Dept. of Cardiology
  More Information

No publications provided

Responsible Party: Dietmar Baensch, Prof. Dr. Dietmar Baensch, University of Rostock
ClinicalTrials.gov Identifier: NCT01767220     History of Changes
Other Study ID Numbers: A 2012-0125
Study First Received: January 7, 2013
Last Updated: January 29, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Rostock:
ventricular tachycardia
endocardial ablation
epicardial ablation

Additional relevant MeSH terms:
Heart Diseases
Tachycardia
Tachycardia, Ventricular
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014