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

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)

Study Overview

• Status: Completed
• Conditions: Tachycardia, Ventricular
• Intervention / Treatment: Device: Saline-Enhanced Radiofrequency Catheter and Ablation System

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
  • Ontario
    • Newmarket, Ontario, Canada, L3Y-2P6
      • Southlake Regional Health Centre
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute - Institut de Cardiologie de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Patient has recurrent, symptomatic, monomorphic VT
2. Patient has drug refractory or drug intolerant VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
3. A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
4. Patient has minimum 3 month ICD interrogation history available for evaluation
5. Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
6. Patient is at least 18 years old
7. Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

Exclusion Criteria

1. Patients with idiopathic VT
2. Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
3. Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk.
4. Patient with myocardial infarction (MI) or unstable angina within previous 60 days
5. Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
6. Patient with class IV (NYHA) heart failure
7. Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet
8. Patient with left ventricular assist device planned or required for the procedure
9. Patients with co-morbidities such that they have less than 1 year life expectancy
10. Patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days of the ablation procedure
11. Patient with thrombocytopenia or other coagulopathy
12. Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test)
13. Patient with other acute illness or active systemic infection (unrelated to VT or its origin)
14. Significant congenital anomaly heart disease or anomaly
15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
16. Patient concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SERF Catheter Ablation; Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter	Device: Saline-Enhanced Radiofrequency Catheter and Ablation System; Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter; Other Names: SERF Ablation System and Durablate™ Ablation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events that are potentially device-related		Within 30 days of ablation
Major Adverse Cardiac Events	MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).	Within 2 days after ablation procedure
Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels		At completion of ablation procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Thermedical, Inc.
• Investigators: Study Director: Douglas L. Packer, MD, Mayo Clinic

Publications and helpful links

General Publications

• Packer DL, Wilber DJ, Kapa S, Dyrda K, Nault I, Killu AM, Kanagasundram A, Richardson T, Stevenson W, Verma A, Curley M; SERF Investigators. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010347. doi: 10.1161/CIRCEP.121.010347. Epub 2022 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: December 11, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: RD-14-001P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided