Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia (STRATUM VT)
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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 |
- 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
- 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
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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 |
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| Contact: Sandeep Gangireddy, MD | 212-241-6541 | Sandeep.gangireddy@mssm.edu |
| United States, Alabama | |
| University of Alabama - Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: G. Neal Kay, MD 205-934-9999 | |
| Principal Investigator: G. Neal Kay, MD | |
| United States, Illinois | |
| Loyola University | Suspended |
| Maywood, Illinois, United States, 60153 | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: William Stevenson, MD 857-307-1948 | |
| Principal Investigator: William Stevenson, MD | |
| Beth Israel-Deaconess Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Mark E. Josephson, MD 617-667-8800 | |
| Principal Investigator: Mark E. Josephson, MD | |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Sandeep Gangireddy, MD 212-241-6541 Sandeep.gangireddy@mssm.edu | |
| Principal Investigator: Marc Miller, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Francis Marchlinski, MD francis.marchlinski@uphs.upenn.edu | |
| Principal Investigator: Francis Marchlinski, MD | |
| Brazil | |
| Hospital Regional Sao Jose | Not yet recruiting |
| Santa Catarina, Brazil | |
| Contact: Andre d'Avila, MD andre.d'avila@mountsinai.org | |
| Principal Investigator: Andre d'Avila, MD | |
| Canada, Ontario | |
| Southlake Regional Health Center | Not yet recruiting |
| Newmarket, Ontario, Canada | |
| Contact: Yaariv Khaykin, MD y.khaykin@utoronto.ca | |
| Principal Investigator: Yaariv Khaykin, MD | |
| Czech Republic | |
| Homolka Hospital | Not yet recruiting |
| Prague, Czech Republic | |
| Contact: Petr Neuzil, MD petr.neuzil@homolka.cz | |
| Principal Investigator: Petr Neuzil, MD | |
| Italy | |
| San Raffaele Hospital | Not yet recruiting |
| Milan, Italy | |
| Contact: Paolo Della Bella, MD dellabella.paolo@hsr.it | |
| Principal Investigator: Paolo Della Bella, MD | |
| Principal Investigator: | Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai |
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 |
| Last Updated: | March 19, 2013 |
| 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 |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013