Ventricular Tachycardia Clinical Trial
— VTeeeOfficial title:
Primary Endo- and Epicardial vs. Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease (VTeee)
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Rostock | Rostock | Mecklenburg-Vorpommern |
Lead Sponsor | Collaborator |
---|---|
University of Rostock |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | percentage of VT substrates which can only be abolished by epicardial ablation | 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. | date of VT ablation - up to 3 to 5 days | No |
Secondary | 12 lead ECG features typical for epicardial VT substrates | 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. | date of VT ablation up to 3 to 5 days | No |
Secondary | percentage of epicardial VT substrates referred to the underlying cardiac disease | 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. | date of VT ablation - up to 3 to 5 days | No |
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