RECRUITING

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Quick Facts

Study Start:2025-08-09

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05337241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject has structural heart disease 2. Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria: 1. 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 2. Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND 3. 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 4. 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. 3. Subject is at least 18 years old 4. Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT 5. Subject is able to provide informed consent	1. 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) 2. Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum 3. Subject with a prior ablation within 4 weeks of planned study ablation 4. Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation 5. Only PVCs are induced during mapping for the study ablation 6. No clinical VT induced during mapping for the study ablation 7. Planned use of a non-study ablation catheter 8. Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure) 9. 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. 10. 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. 11. Subjects with NYHA Class IV heart failure 12. Renal dysfunction with eGFR \<30 ml/min/1.73mP2 13. Subject with known coagulopathy or other condition likely to increase risk of periprocedural bleeding 14. Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event 15. Subject with a mechanical aortic valve, mechanical mitral valve, or MitraClip 16. Subject with flail mitral leaflet or severe aortic stenosis 17. Subject with LAA occlusion device 18. Subject with a congenital heart defect except patent foramen ovale (PFO) 19. Subject with suspected life expectancy of less than 1 year 20. Subject with myocardial infarction (MI) or unstable angina (UA) within previous 90 days 21. Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 90 days 22. Subject with known untreated significant ischemic coronary artery disease, acute illness (unrelated to VT or its origin) or active systemic infection. 23. Subject with left ventricular assist device planned or required for the procedure 24. Females who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test) 25. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention including heparin and ionic contrast media 26. Contraindication to cardiac CT 27. Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results 28. 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 29. Subject is not willing or is unable to participate in all study procedures and follow-up requirements

Inclusion Criteria

Exclusion Criteria

1. Subject has structural heart disease
2. Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria:
1. 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
2. Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
3. 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
4. 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.
3. Subject is at least 18 years old
4. Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT
5. Subject is able to provide informed consent

1. 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)
2. Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
3. Subject with a prior ablation within 4 weeks of planned study ablation
4. Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
5. Only PVCs are induced during mapping for the study ablation
6. No clinical VT induced during mapping for the study ablation
7. Planned use of a non-study ablation catheter
8. Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure)
9. 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.
10. 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.
11. Subjects with NYHA Class IV heart failure
12. Renal dysfunction with eGFR \<30 ml/min/1.73mP2
13. Subject with known coagulopathy or other condition likely to increase risk of periprocedural bleeding
14. Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event
15. Subject with a mechanical aortic valve, mechanical mitral valve, or MitraClip
16. Subject with flail mitral leaflet or severe aortic stenosis
17. Subject with LAA occlusion device
18. Subject with a congenital heart defect except patent foramen ovale (PFO)
19. Subject with suspected life expectancy of less than 1 year
20. Subject with myocardial infarction (MI) or unstable angina (UA) within previous 90 days
21. Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 90 days
22. Subject with known untreated significant ischemic coronary artery disease, acute illness (unrelated to VT or its origin) or active systemic infection.
23. Subject with left ventricular assist device planned or required for the procedure
24. Females who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
25. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention including heparin and ionic contrast media
26. Contraindication to cardiac CT
27. Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
28. 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
29. Subject is not willing or is unable to participate in all study procedures and follow-up requirements

Contacts and Locations

Study Contact

Michael Curley, PhD

CONTACT

617-899-9843

mcurley@thermedical.com

Mary DeVoe

CONTACT

m.devoe@thermedical.com

Principal Investigator

Michael Curley, PhD

STUDY_DIRECTOR

Thermedical, Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Thermedical, Inc.

Michael Curley, PhD, STUDY_DIRECTOR, Thermedical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-09

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-08-09

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

Refractory Ventricular Tachycardia