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

This study has been terminated.
(low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546207
First Posted: March 7, 2012
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention
Ventricular Tachycardia Catheter Ablation Tachycardia, Ventricular Procedure: catheter-based ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Catheter Ablation [ Time Frame: at time of catheter ablation procedure (intraoperative) ]
    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


Secondary Outcome Measures:
  • ICD Interrogation [ Time Frame: baseline and 6 months follow-up ]
    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.

  • Procedural Safety [ Time Frame: 1 week post-op ]
    2) Procedural safety as defined by the number of complication within 1week associated with the procedure.

  • Signal-Average ECG [ Time Frame: baseline and post-op day one after procedure ]
    Relationship between change in pre/post saECG and success of the step-wise ablation strategy


Enrollment: 4
Study Start Date: September 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546207


Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Brazil
Hospital Regional Sao Jose
Santa Catarina, Brazil
Canada, Ontario
Southlake Regional Health Center
Newmarket, Ontario, Canada
Czech Republic
Homolka Hospital
Prague, Czech Republic
Italy
San Raffaele Hospital
Milan, Italy
Sponsors and Collaborators
Vivek Reddy
Biosense Webster, Inc.
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01546207     History of Changes
Other Study ID Numbers: GCO 12-0045
First Submitted: February 13, 2012
First Posted: March 7, 2012
Results First Submitted: August 20, 2013
Results First Posted: April 24, 2014
Last Update Posted: July 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
ventricular tachycardia
catheter ablation
VT

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes