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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994446
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Thermedical, Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Device: Saline-Enhanced Radiofrequency Catheter and Ablation System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
Actual Study Start Date : December 2016
Actual Primary Completion Date : April 21, 2021
Actual Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SERF Catheter Ablation
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
 Device: Saline-Enhanced Radiofrequency Catheter and Ablation System
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
Other Name: SERF Ablation System and Durablate™ Ablation Catheter


Outcome Measures
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Primary Outcome Measures :
  1. Serious Adverse Events that are potentially device-related [ Time Frame: Within 30 days of ablation ]
  2. Major Adverse Cardiac Events [ Time Frame: Within 2 days after ablation procedure ]
    MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).

  3. Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels [ Time Frame: At completion of ablation procedure ]

Secondary Outcome Measures :
  1. Intraprocedural non-inducibility and/or scar homogenization of target VT [ Time Frame: At completion of ablation procedure ]
  2. Elimination of the target VT and/or reduction in number of VT episodes [ Time Frame: Within first 6 months of ablation procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994446


Locations
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Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y-2P6
Canada, Quebec
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montréal, Quebec, Canada, H1T 1C8
Canada
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
Sponsors and Collaborators
Thermedical, Inc.
Investigators
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Study Director: Douglas L. Packer, MD Mayo Clinic
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thermedical, Inc.
ClinicalTrials.gov Identifier: NCT02994446    
Other Study ID Numbers: RD-14-001P
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes