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

NCT02994446 | Completed DMC

• 1 other identifier: RD-14-001P
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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)

Conditions

Tachycardia, Ventricular

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

SERF Catheter Ablation

EXPERIMENTAL

Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Device: Saline-Enhanced Radiofrequency Catheter and Ablation System

Interventions

Saline-Enhanced Radiofrequency Catheter and Ablation System DEVICE

Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Also known as: SERF Ablation System and Durablate™ Ablation Catheter

SERF Catheter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has recurrent, symptomatic, monomorphic VT
• 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
• A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
• Patient has minimum 3 month ICD interrogation history available for evaluation
• Patient has LVEF \> 20%, confirmed by echo or comparable technique during baseline evaluation
• Patient is at least 18 years old
• Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

You may not qualify if:

• Patients with idiopathic VT
• Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
• 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.
• Patient with myocardial infarction (MI) or unstable angina within previous 60 days
• Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
• Patient with class IV (NYHA) heart failure
• Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet
• Patient with left ventricular assist device planned or required for the procedure
• Patients with co-morbidities such that they have less than 1 year life expectancy
• 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
• Patient with thrombocytopenia or other coagulopathy
• Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test)
• Patient with other acute illness or active systemic infection (unrelated to VT or its origin)
• Significant congenital anomaly heart disease or anomaly
• Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.

Sponsors & Collaborators

• Thermedical, Inc.: lead

Study Sites (3)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y-2P6, Canada

Location

Montreal Heart Institute - Institut de Cardiologie de Montréal

Montreal, Quebec, H1T 1C8, Canada

Location

Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Canada

Location

Related Publications (1)

• 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.

  PMID: 35776711 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas L. Packer, MD

  Mayo Clinic

  STUDY DIRECTOR

• Atul Verma, MD

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: April 21, 2021
• Study Completion: October 4, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CA (3)