Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Thermedical, Inc.
Study ID
NCT05337241
Status
Recruiting
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Conditions

  • Refractory Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saline Enhanced Radiofrequency (SERF) Ablation — DEVICE
    The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates

Study Details

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.

Key Dates

Start date
Aug 9, 2025
Status verified
Aug 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm treatment
    All subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device.

Primary Outcome Measure

Primary Efficacy (Acute Interim) [ Time Frame: At end of ablation procedure (ablation procedure occurs on a single day) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Sarah Houston
[email protected]
William Maddox, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Mary Gnap
David J Callans (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Kavin Panneerselvam
[email protected]
Jeffrey Winterfield, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Terry Weyand
[email protected]
William Stevenson, MD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthcareSalt Lake CityUtah84124
Douglas L Packer, MD
Douglas Packer <[email protected]>
5072693280
Douglas L Packer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, ALHospital of the University of Pennsylvania· Philadelphia, PAMedical University of South Carolina· Charleston, SCVanderbilt University Medical Center· Nashville, TNIntermountain Healthcare· Salt Lake City, UT