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

Thermedical

Status: Completed

Conditions: Tachycardia, Ventricular

Treatments: Device: Saline-Enhanced Radiofrequency Catheter and Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02994446

RD-14-001P

Details and patient eligibility

About

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)

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

SERF Catheter Ablation

Experimental group

Description:

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

Treatment:

Device: Saline-Enhanced Radiofrequency Catheter and Ablation System