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

Tachycardia, Ventricular Clinical Trial

— SERF-VT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994446
• Other study ID #: RD-14-001P
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 4, 2021

Study information

• Verified date: April 2022
• Source: Thermedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 4, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• Saline-Enhanced Radiofrequency Catheter and Ablation System
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Locations

Country	Name	City	State
Canada	Montreal Heart Institute - Institut de Cardiologie de Montréal	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Thermedical, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events that are potentially device-related		Within 30 days of ablation
Primary	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
Primary	Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels		At completion of ablation procedure
Secondary	Intraprocedural non-inducibility and/or scar homogenization of target VT		At completion of ablation procedure
Secondary	Elimination of the target VT and/or reduction in number of VT episodes		Within first 6 months of ablation procedure