Clinical trial NCT02994446: Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
Official title: Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Lead sponsor: Thermedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Serious Adverse Events that are potentially device-related
timeFrame: Within 30 days of ablation
measure: Major Adverse Cardiac Events
timeFrame: Within 2 days after ablation procedure
measure: Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels
timeFrame: At completion of ablation procedure
Secondary outcomes:
measure: Intraprocedural non-inducibility and/or scar homogenization of target VT
timeFrame: At completion of ablation procedure
measure: Elimination of the target VT and/or reduction in number of VT episodes
timeFrame: Within first 6 months of ablation procedure
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute - Institut de Cardiologie de Montréal
state: Quebec
city: Québec
country: Canada
facility: Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Mayo Clinic
name: Douglas L. Packer, MD
role: STUDY_DIRECTOR
affiliation: Southlake Regional Health Centre
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.