CClinicalTrials.gg
CompletedNCT03628534SERF VT EFSUpdated Aug 10, 2022

SERF VT Ablation Early Feasibility Study (EFS)

An interventional study of Saline Enhanced Radiofrequency (SERF) ablation in Ventricular Tachycardia, Arrythmia and Heart Diseases, sponsored by Thermedical, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

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

From the registry’s dates

  • Primary completion was Jun 2021, 5 years 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.

Read the detailed description

The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.

02

Conditions studied

  • Ventricular Tachycardia
  • Arrythmia
  • Heart Diseases
  • Cardiovascular Diseases

Keywords

  • Cardiac Arrhythmia
  • Ventricular Tachycardia
  • Arrhythmia
  • Pathological processes
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 16 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases 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.

04

Who can participate

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

Inclusion criteria

  1. Subject has sustained, monomorphic VT
  2. Subject has recurrent, symptomatic VT
  3. Subject has drug refractory or drug intolerant sustained 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
  4. ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that is suspected to be the same VT as initially targeted in a prior ablation
  5. Subject has minimum 3-month ICD interrogation history available for evaluation
  6. Subject has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
  7. Subject is at least 18 years old
  8. Subject 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. Subjects with VT of idiopathic origin
  2. Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin
  3. Subjects with VTs of septal origin require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system; Subjects 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. Subject with myocardial infarction (MI) or unstable angina within previous 60 days
  5. Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
  6. Subject with class IV (NYHA) heart failure
  7. Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve
  8. Subject with left ventricular assist device planned or required for the procedure
  9. Subjects with co-morbidities such that they have less than 1-year life expectancy
  10. Subject with evidence of intracardiac and/or laminated thrombus (in the left atrium including left atrial appendage or the left ventricle) evident by cardiac CT or transesophageal echo (TEE) and transthoracic echo (TTE) (with contrast if indicated) within 48 hours prior to ablation procedure
  11. Subject 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. Subject with other acute illness or active systemic infection (unrelated to VT or its origin)
  14. Significant congenital heart disease or cardiac anomaly
  15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
  16. Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
05

Study design

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

Study arms

  • Experimental
    single arm

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

    Device: Saline Enhanced Radiofrequency (SERF) ablation

Interventions

  • DeviceSaline Enhanced Radiofrequency (SERF) ablation

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

    Also known as: Durablate Catheter and Thermedical Ablation System

06

What researchers measure

Primary outcomes

  1. EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure.

    Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).

    Time frame: By the end of the procedure

  2. SAFETY: SAEs that are probably or definitely device related within 30 days

    Time frame: within 30 days

07

Study locations

3 sites
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Vanderbilt Heart
    Nashville, Tennessee 37232, United States
08

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03628534
Lead sponsor
Thermedical, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Aug 14, 2018
Start date
Nov 1, 2018
Primary completion
Jun 30, 2021
Completion
Jul 31, 2022
Last update
Aug 10, 2022

Study contacts

Douglas Packer, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion