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

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.

Study Overview

• Status: Terminated
• Conditions: Ventricular Tachycardia; Tachycardia, Ventricular; Catheter Ablation
• Intervention / Treatment: Procedure: catheter-based ablation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina, Brazil
    • Hospital Regional Sao Jose
• Canada
  • Ontario
    • Newmarket, Ontario, Canada
      • Southlake Regional Health Center
• Czechia
  • Prague, Czechia
    • Homolka Hospital
• Italy
  • Milan, Italy
    • San Raffaele Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama - Birmingham
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel-Deaconess Medical Center
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: catheter-based ablation; catheter ablation - a medical procedure used to treat some types of arrhythmia	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Procedural Safety	2) Procedural safety as defined by the number of complication within 1week associated with the procedure.	1 week post-op
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

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: catheter ablation; ventricular tachycardia; VT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: GCO 12-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No