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

NCT ID: NCT02994446

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-10-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SERF Catheter Ablation

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

Group Type: EXPERIMENTAL

Saline-Enhanced Radiofrequency Catheter and Ablation System

Intervention Type: DEVICE

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

Interventions

Saline-Enhanced Radiofrequency Catheter and Ablation System

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

Intervention Type: DEVICE

Other Intervention Names

SERF Ablation System and Durablate™ Ablation Catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thermedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas L. Packer, MD

Role: STUDY_DIRECTOR

Mayo Clinic

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Southlake Regional Health Centre

Locations

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Montreal Heart Institute - Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

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

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35776711 (View on PubMed)

Other Identifiers

RD-14-001P

Identifier Type: -

Identifier Source: org_study_id