Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Ventricular Tachycardia
• Intervention / Treatment: Device: Saline Enhanced Radiofrequency (SERF) Ablation

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Curley, PhD; Phone Number: 617-899-9843; Email: mcurley@thermedical.com
• Study Contact Backup: Name: Mary DeVoe; Email: m.devoe@thermedical.com

Study Locations

• Canada
  • Québec, Canada
    • Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec
    • Principal Investigator: Isabelle Nault, MD
    • Contact: Paule Banville; Email: paule.banville@criucpq.ulaval.ca
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute - Institut de Cardiologie de Montreal
      • Principal Investigator: Katia Dyrda, MD
    • Montréal, Quebec, Canada, H9S1H4
      • McGill University Health Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Contact: Sarah Houston; Email: scarlson@uabmc.edu
      • Principal Investigator: William Maddox, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Christine Pellegrini; Email: cpellegrini@bwh.harvard.edu
      • Principal Investigator: Usha Tedrow, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55092
      • Mayo Clinic
      • Contact: Douglas Packer, MD
      • Principal Investigator: Douglas Packer, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
      • Contact: Mary Gnap
      • Principal Investigator: David J Callans
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Kavin Panneerselvam; Email: panneeer@musc.edu
      • Principal Investigator: Jeffrey Winterfield, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
      • Principal Investigator: William Stevenson, MD
      • Contact: Terry Weyand; Email: terry.l.weyand@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion 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

Exclusion Criteria:

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm treatment; All subjects meeting inclusion/exclusion criteria and successfully consented will be treated with the study device.	Device: Saline Enhanced Radiofrequency (SERF) Ablation; The Durablate intramural needle catheter delivers heated saline to target tissue in the left ventricle to target mid-myocardial and epicardial VT substrates; Other Names: Intramural Needle Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety	Per subject composite of cardiovascular-related and procedure-related major complications through 7 days post-study ablation procedure	7 days from intervention

Collaborators and Investigators

• Sponsor: Thermedical, Inc.
• Investigators: Study Director: Michael Curley, PhD, Thermedical, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: CP-90001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be de-identified and protected according to HIPAA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes