Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia

Not Applicable

Completed

• Conditions: Tachycardia, Ventricular
• Interventions: Device: Saline-Enhanced Radiofrequency Catheter and Ablation System

• 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

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Primary Completion: 2021-04-21
• Study Completion: 2021-10-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28

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

Arm && Interventions

Group	Intervention	Description
SERF Catheter Ablation	Saline-Enhanced Radiofrequency Catheter and Ablation System	Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

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

Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Canada

Montreal Heart Institute - Institut de Cardiologie de Montréal; 🇨🇦 Montréal, Quebec, Canada