Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia (STRATUM VT)

Vivek Reddy

Status

Terminated

Conditions

Tachycardia, Ventricular

Catheter Ablation

Ventricular Tachycardia

Treatments

Procedure: catheter-based ablation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01546207

GCO 12-0045

Details and patient eligibility

About

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.

Full description

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.

Enrollment

4 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.