Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
1 other identifier
interventional
130
2 countries
7
Brief Summary
The Thermedical Ablation System and Durablate catheter is indicated for use in patients with recurrent, sustained, monomorphic ventricular tachycardia (SMVT) refractory to drug therapy and conventional (approved) catheter ablation. Subjects with recurrent, SMVT refractory to drug therapy and conventional catheter ablation who are not eligible for, or will not likely benefit from repeat endocardial ablation using an approved catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
August 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 14, 2025
August 1, 2024
1.9 years
March 21, 2022
August 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Efficacy (Acute Interim)
Percentage of target clinical VTs that are non-inducible at end of the study ablation procedure (if PES performed at procedure conclusion)
At end of ablation procedure (ablation procedure occurs on a single day)
Primary Efficacy (Long Term)
Percentage of subjects who are free from recurrent monomorphic VT
6 month post ablation
Secondary Outcomes (1)
Primary Safety
7 days from intervention
Study Arms (1)
Single arm treatment
EXPERIMENTALAll subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device.
Interventions
The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates
Eligibility Criteria
You may qualify if:
- Subject has structural heart disease
- Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria:
- At least 3 episodes of the MMVT have been treated with ATP and/or shock, OR at least 2 episodes were treated with shock AND
- Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
- Occurred despite treatment with at least one Class III antiarrhythmic after last ablation or treatment with a Class III antiarrhythmic is not tolerated or is contraindicated AND
- VT has recurred despite VT ablation at one of the investigational centers UORU the investigator documents the reason that the subject is unlikely to benefit from a repeat ablation using a conventional, approved catheter.
- Subject is at least 18 years old
- Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT
- Subject is able to provide informed consent
You may not qualify if:
- Idiopathic VT (VT occurring in subjects without structural heart disease \[including the absence of LGE on MRI, if performed\], metabolic abnormalities or long QT syndrome)
- Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
- Subject with a prior ablation within 4 weeks of planned study ablation
- Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
- Only PVCs are induced during mapping for the study ablation
- No clinical VT induced during mapping for the study ablation
- Planned use of a non-study ablation catheter
- Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure)
- Subject with evidence of any right- or left-sided (including left atrium, left atrial appendage and left ventricle) intracardiac thrombus OR pericardial effusion (except chronic trivial) reported on required pre-ablation imaging (CT, MRI, or echocardiography) or seen on required procedural intracardiac echocardiography (ICE) prior to study ablation catheter insertion.
- Subjects with atrial fibrillation/flutter (paroxysmal, persistent, or permanent) without uninterrupted anticoagulation for at least 3 weeks immediately prior to the date of ablation procedure. (Interruption of anticoagulation in the day(s) just prior to ablation will be left to physician decision based upon subject's risk of stroke, anticoagulation agent, renal status, and bleed/embolic risk status with recommendation to consider bridging for high-risk subjects.
- Subjects with NYHA Class IV heart failure
- Renal dysfunction with eGFR \<30 ml/min/1.73mP2
- Subject with known coagulopathy or other condition likely to increase risk of periprocedural bleeding
- Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event
- Subject with a mechanical aortic valve, mechanical mitral valve, or MitraClip
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Intermountain Healthcare
Salt Lake City, Utah, 84124, United States
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8, Canada
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Curley, PhD
Thermedical, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 20, 2022
Study Start
August 9, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 14, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
All data will be de-identified and protected according to HIPAA