Ventricular Tachycardia Clinical Trial
— VISTAOfficial title:
Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Based on Scar Mapping; on the Long Term Success Rate of VT Ablation
This study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Previous Myocardial infarction - Symptomatic, drug-refractory and haemodynamically stable VT following CAD - Undergoing a VT ablation - Implanted ICD Exclusion Criteria: - Documented valvular heart disease - Acute myocardial infarction within the preceding 1 month - Unstable angina - Prolonged QT interval - Patients with hemorrhagic or thrombophilic disorders - Documented intra-atrial thrombus, tumor or other conditions which prevent easy catheter introduction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St.David's Medical Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Cardiac Arrhythmia Research Foundation | California Pacific Medical Center, Case Western Reserve University, Catholic University, Italy, Ospedale dell'Angelo, Mestre, Venice, Italy, RCCS Monzino Hospital, Milan, Italy, Southlake Regional Health Centre, Stanford University, University of Kansas Medical Center, University of Rome Tor Vergata |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of any sustained VT in the post-ablation period as demonstrated by electronic documentation Procedural complications associated with prolonged use of radiofrequency (RF) energy such as perforation, cardiac tamponade | 48 hours | Yes | |
Secondary | Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions | 12 months | Yes |
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