Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
Not Applicable
Completed
- Conditions
- Tachycardia, Ventricular
- Registration Number
- NCT02994446
- Lead Sponsor
- Thermedical, Inc.
- Brief Summary
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events Within 2 days after ablation procedure MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).
Serious Adverse Events that are potentially device-related Within 30 days of ablation Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels At completion of ablation procedure
- Secondary Outcome Measures
Name Time Method Intraprocedural non-inducibility and/or scar homogenization of target VT At completion of ablation procedure Elimination of the target VT and/or reduction in number of VT episodes Within first 6 months of ablation procedure
Trial Locations
- Locations (3)
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Montreal Heart Institute - Institut de Cardiologie de Montréal
🇨🇦Montréal, Quebec, Canada
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Canada
Southlake Regional Health Centre🇨🇦Newmarket, Ontario, Canada