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CompletedNCT02994446SERF-VTUpdated Apr 28, 2022

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

An interventional study of Saline-Enhanced Radiofrequency Catheter and Ablation System in Tachycardia, Ventricular, sponsored by Thermedical, Inc.. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.

Sponsored by Thermedical, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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)

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Conditions studied

  • Tachycardia, Ventricular
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In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 25 is below the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Thermedical, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    SERF Catheter Ablation

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

    Device: Saline-Enhanced Radiofrequency Catheter and Ablation System

Interventions

  • DeviceSaline-Enhanced Radiofrequency Catheter and Ablation System

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

    Also known as: SERF Ablation System and Durablate™ Ablation Catheter

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What researchers measure

Primary outcomes

  1. Serious Adverse Events that are potentially device-related

    Time frame: Within 30 days of ablation

  2. 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).

    Time frame: Within 2 days after 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 outcomes

  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

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Study locations

3 sites
  • Southlake Regional Health Centre
    Newmarket, Ontario L3Y-2P6, Canada
  • Montreal Heart Institute - Institut de Cardiologie de Montréal
    Montréal, Quebec H1T 1C8, Canada
  • Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
    Québec, Canada
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References and documents

Publications

  • 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. PubMed 35776711 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02994446
Lead sponsor
Thermedical, Inc.
Responsible party
Sponsor
First posted
Dec 15, 2016
Start date
Dec 2016
Primary completion
Apr 21, 2021
Completion
Oct 4, 2021
Last update
Apr 28, 2022

Study contacts

Douglas L. Packer, MD
study director · Mayo Clinic
Atul Verma, MD
principal investigator · Southlake Regional Health Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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