Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— STRATUM VT  

Official title:

Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01546207
• Other study ID #: GCO 12-0045
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Ablation
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	Hospital Regional Sao Jose	Santa Catarina
Canada	Southlake Regional Health Center	Newmarket	Ontario
Czechia	Homolka Hospital	Prague
Italy	San Raffaele Hospital	Milan
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Beth Israel-Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Loyola University	Maywood	Illinois
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czechia,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter Ablation	The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia	at time of catheter ablation procedure (intraoperative)
Secondary	ICD Interrogation	Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.	baseline and 6 months follow-up
Secondary	Procedural Safety	2) Procedural safety as defined by the number of complication within 1week associated with the procedure.	1 week post-op
Secondary	Signal-Average ECG	Relationship between change in pre/post saECG and success of the step-wise ablation strategy	baseline and post-op day one after procedure