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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
February 13, 2012
March 7, 2012
August 20, 2013
April 24, 2014
July 27, 2016
September 2011
August 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01546207 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Ventricular Tachycardia
  • Catheter Ablation
  • Tachycardia, Ventricular
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
catheter-based ablation
catheter ablation - a medical procedure used to treat some types of arrhythmia
Intervention: Procedure: catheter-based ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
August 2013
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Czech Republic,   Italy,   United States
 
 
NCT01546207
GCO 12-0045
Yes
Not Provided
Plan to Share IPD: No
Vivek Reddy, Icahn School of Medicine at Mount Sinai
Vivek Reddy
Biosense Webster, Inc.
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP