Refractory Ventricular TachycardiaNCT05337241
Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
A study testing Saline Enhanced Radiofrequency (SERF) Ablation in people with Refractory Ventricular Tachycardia, run by Thermedical, Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ventricular Tachycardia
- What is being tested?
- Saline Enhanced Radiofrequency (SERF) Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
- Subject with flail mitral leaflet or severe aortic stenosis
- Subject with LAA occlusion device
- Subject with a congenital heart defect except patent foramen ovale (PFO)
- Subject with suspected life expectancy of less than 1 year
- Subject with myocardial infarction (MI) or unstable angina (UA) within previous 90 days
- Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 90 days
- Subject with known untreated significant ischemic coronary artery disease, acute illness (unrelated to VT or its origin) or active systemic infection.
- Subject with left ventricular assist device planned or required for the procedure
- Females who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
- Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention including heparin and ionic contrast media
- Contraindication to cardiac CT
- Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
- Subject with a condition (including a chronic illness) or circumstance that the investigator feels puts the subject at an unacceptable risk for participation in the study or may interfere with quality data collection or study results
- Subject is not willing or is unable to participate in all study procedures and follow-up requirements
- -
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Mary DeVoe contact
7 sites in 2 countries
United States5 sites, 5 recruiting
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Sarah Houston, scarlson@uabmc.edu
William Maddox, MD
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Kavin Panneerselvam, panneeer@musc.edu
Jeffrey Winterfield, MD
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Terry Weyand, terry.l.weyand@vumc.org
William Stevenson, MD
- Not yet recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Gnap
David J Callans
- Recruiting
Intermountain Healthcare
Salt Lake City, Utah, 84124
Douglas L Packer, MD, 5072693280, Douglas Packer <Douglas.Packer@imail.org>
Douglas L Packer, MD
Canada2 sites, 2 recruiting
- Recruiting
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8
Caroline Girard, 514-376-3330 ext. 4058, caroline.girard@icm-mhi.org
Katia Dyrda, MD
- Not yet recruiting
Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
Paule Banville, paule.banville@criucpq.ulaval.ca
Isabelle Nault, MD
About this study
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.
Read the detailed description
This is a staged, non-randomized, open-label, single group, interventional study to be conducted at up to 25 investigational sites to evaluate the safety and efficacy of the Thermedical Ablation System with the Durablate Ablation Catheter (investigational device) in subjects with recurrent, sustained, monomorphic ventricular tachycardia (VT) refractory to drug therapy and conventional catheter ablation.
Subjects will be consented (enrolled) and screened prior to the study ablation procedure. 154 subjects will have a study ablation procedure with the investigational device. Follow-up will occur at 7 days, 30 days, 3 months and 6 months.
The single arm design of the proposed study reflects the nature of the study population. The Thermedical Ablation System was designated as a Breakthrough technology in part because no currently approved device specifically treats this refractory patient population.
- Conditions
- Refractory Ventricular Tachycardia
- Being tested
- Saline Enhanced Radiofrequency (SERF) Ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Enhanced Radiofrequency (SERF) AblationDevice
Also called Intramural Needle Ablation
The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates
| Study group | Role | What they receive |
|---|---|---|
| Single arm treatment | Experimental | All subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device. Receives: Device: Saline Enhanced Radiofrequency (SERF) Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 6 month post ablation
Secondary outcomes (1)
Primary Safety
Per subject composite of cardiovascular-related and procedure-related major complications through 7 days post-study ablation procedure
Measured: 7 days from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start9 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thermedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Curley, PhD, Study director, Thermedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337241
- Sponsor's protocol ID
- CP-90001
- Status last verified
- Aug 2024
- First submitted
- 21 Mar 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be de-identified and protected according to HIPAA
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
- ClinicalTrials.gov ID
- NCT05337241
- Acronym / sponsor ID
- CP-90001
- Conditions
- Refractory Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Thermedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a staged, non-randomized, open-label, single group, interventional study to be conducted at up to 25 investigational sites to evaluate the safety and efficacy of the Thermedical Ablation System with the Durablate Ablation Catheter (investigational device) in subjects with recurrent, sustained, monomorphic ventricular tachycardia (VT) refractory to drug therapy and conventional catheter ablation.
Subjects will be consented (enrolled) and screened prior to the study ablation procedure. 154 subjects will have a study ablation procedure with the investigational device. Follow-up will occur at 7 days, 30 days, 3 months and 6 months.
The single arm design of the proposed study reflects the nature of the study population. The Thermedical Ablation System was designated as a Breakthrough technology in part because no currently approved device specifically treats this refractory patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm treatment | Experimental | Device: Saline Enhanced Radiofrequency (SERF) AblationAll subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Enhanced Radiofrequency (SERF) AblationAlso: Intramural Needle AblationThe Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates | Device | Single arm treatment |
Primary outcome
Primary Efficacy (Acute Interim)
Time frame: At end of ablation procedure (ablation procedure occurs on a single day)
Percentage of target clinical VTs that are non-inducible at end of the study ablation procedure (if PES performed at procedure conclusion)
Primary Efficacy (Long Term)
Time frame: 6 month post ablation
Percentage of subjects who are free from recurrent monomorphic VT
1 secondary outcome
Primary Safety
Time frame: 7 days from intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. All data will be de-identified and protected according to HIPAA
Related trials for Refractory Ventricular Tachycardia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Not yet recruiting
Cardiac Radioablation for VT
Ventricular Tachycardia, Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary DeVoe contact
Michael Curley, PhD study director
Thermedical, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Enhanced Radiofrequency (SERF) Ablation in people with Refractory Ventricular Tachycardia, run by Thermedical, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Curley, PhD (617-899-9843, mcurley@thermedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy (Acute Interim) (time frame: At end of ablation procedure (ablation procedure occurs on a single day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.