Endo- and Epicardial vs. Endocardial Ablation of Ventricular Tachycardia in Patients With Cardiac Disease (VTeee)
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|ClinicalTrials.gov Identifier: NCT01767220|
Recruitment Status : Unknown
Verified January 2013 by Dietmar Baensch, University of Rostock.
Recruitment status was: Recruiting
First Posted : January 14, 2013
Last Update Posted : January 30, 2014
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 or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Procedure: Strategy 1 - endocardial ablation Procedure: Strategy 2 - endocardial and epicardial ablation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Endo- and Epicardial vs. Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease (VTeee)|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
U.S. FDA Resources
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.
- recurrence of any VT [ Time Frame: up to 12 months after the date of VT ablation ]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.
- percentage of VT substrates which can only be abolished by epicardial ablation [ Time Frame: date of VT ablation - up to 3 to 5 days ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767220
|Contact: Joerg Lauschke, Dr.||email@example.com|
|Contact: Dietmar Baensch, Prof. Dr.||firstname.lastname@example.org|
|University Hospital of Rostock||Recruiting|
|Rostock, Mecklenburg-Vorpommern, Germany, 18057|
|Contact: Joerg Lauschke, Dr. med. 0049-381-494-7797 email@example.com|
|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.|
|Principal Investigator:||Dietmar Baensch, Prof. Dr.||University Hospital of Rostock, Dept. of Cardiology|