Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

NCT01546207 | Terminated Results DMC

• 1 other identifier: GCO 12-0045
• Study Type: interventional
• Target: 4
• Locations: 5 countries
• Sites: 10

Brief 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.

Conditions

Ventricular Tachycardia; Catheter Ablation; Tachycardia, Ventricular

Keywords

ventricular tachycardia; catheter ablation; VT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ICD Interrogation

  baseline and 6 months follow-up

• Procedural Safety

  1 week post-op

• Signal-Average ECG

  baseline and post-op day one after procedure

Study Arms (1)

catheter-based ablation

OTHER

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

Procedure: catheter-based ablation

Interventions

catheter-based ablation 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

catheter-based ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead
• Biosense Webster, Inc.: collaborator

Study Sites (10)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel-Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital Regional Sao Jose

Santa Catarina, Brazil

Location

Southlake Regional Health Center

Newmarket, Ontario, Canada

Location

Homolka Hospital

Prague, Czechia

Location

San Raffaele Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to poor enrollment. Data analysis not done - there is not enough data for meaningful analysis.

Results Point of Contact

• Title: Dr. Vivek Y. Reddy
• Organization: Icahn School of Medicine at Mount Sinai

vivek.reddy@mountsinai.org

212-241-7114

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Professor of Medicine

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: March 7, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 13, 2020
• Results First Posted: April 24, 2014

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); IT (1); CZ (1); CA (1); US (6)