Ventricular Tachycardia Clinical Trial
— STRATUM VTOfficial title:
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
NCT number | NCT01546207 |
Other study ID # | GCO 12-0045 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | August 2013 |
Verified date | December 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Regional Sao Jose | Santa Catarina | |
Canada | Southlake Regional Health Center | Newmarket | Ontario |
Czechia | Homolka Hospital | Prague | |
Italy | San Raffaele Hospital | Milan | |
United States | University of Alabama - Birmingham | Birmingham | Alabama |
United States | Beth Israel-Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | Loyola University | Maywood | Illinois |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Vivek Reddy | Biosense Webster, Inc. |
United States, Brazil, Canada, Czechia, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Catheter Ablation | 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 | at time of catheter ablation procedure (intraoperative) | |
Secondary | ICD Interrogation | 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. | baseline and 6 months follow-up | |
Secondary | Procedural Safety | 2) Procedural safety as defined by the number of complication within 1week associated with the procedure. | 1 week post-op | |
Secondary | Signal-Average ECG | Relationship between change in pre/post saECG and success of the step-wise ablation strategy | baseline and post-op day one after procedure |
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