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Trial record 2 of 164 for:    "Tachycardia, Ventricular" OR "catecholaminergic polymorphic ventricular tachycardia"

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

This study has been terminated.
(low enrollment)
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 24, 2014
Last verified: March 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
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 Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01546207     History of Changes
Other Study ID Numbers: GCO 12-0045
Study First Received: February 13, 2012
Results First Received: August 20, 2013
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
ventricular tachycardia
catheter ablation
VT

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

ClinicalTrials.gov processed this record on November 25, 2014