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

This study is currently recruiting participants.
Verified March 2013 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01546207
First received: February 13, 2012
Last updated: March 19, 2013
Last verified: March 2013

February 13, 2012
March 19, 2013
September 2011
December 2013   (final data collection date for primary outcome measure)
Catheter Ablation [ Time Frame: at time of catheter ablation procedure (intraoperative) ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
50
December 2013
December 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.
Both
18 Years to 90 Years
No
Contact: Sandeep Gangireddy, MD 212-241-6541 Sandeep.gangireddy@mssm.edu
United States,   Brazil,   Canada,   Czech Republic,   Italy
 
NCT01546207
GCO 12-0045
Yes
Vivek Reddy, Mount Sinai School of Medicine
Vivek Reddy
Biosense Webster, Inc.
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2013

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