Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

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The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.

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Detailed Description

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Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.

Conditions

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Ventricular Tachycardia Catheter Ablation Tachycardia, Ventricular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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catheter-based ablation

catheter ablation - a medical procedure used to treat some types of arrhythmia

Group Type OTHER

catheter-based ablation

Intervention Type PROCEDURE

specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia

Interventions

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catheter-based ablation

specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 90 years.
* History of coronary artery disease.
* Presence of, or planned for, an ICD prior to discharge.
* Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.

Exclusion Criteria

* Ventricular arrhythmia not thought to be due to CAD.
* Unstable angina
* CVA within 30 days.
* Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography
* Pregnancy
* Any condition resulting in an absolute contraindication to anticoagulation
* Inability to follow-up at ICD clinic.
* Inability to give informed consent.
* Non-inducible for sustained monomorphic ventricular tachycardia.
* Prior substrate guided ablation.
* Definite need for epicardial ablation, as determined by the primary operator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No