SERF VT Ablation Early Feasibility Study (EFS) (SERF VT EFS)

• ClinicalTrials.gov Identifier: NCT03628534
• Recruitment Status: Completed
• First Posted: August 14, 2018
• Last Update Posted: August 10, 2022
• Sponsor: Thermedical, Inc.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Thermedical, Inc.

Tracking Information

• First Submitted Date: July 26, 2018
• First Posted Date: August 14, 2018
• Last Update Posted Date: August 10, 2022
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2022)

• EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure. [ Time Frame: By the end of the procedure ]
  Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).
• SAFETY: SAEs that are probably or definitely device related within 30 days [ Time Frame: within 30 days ]

Original Primary Outcome Measures (submitted: August 8, 2018)

• EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure. [ Time Frame: By the end of the procedure ]
  Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).
• SAFETY: Serious adverse events that are probably or definitely device related related [ Time Frame: within 30 days ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SERF VT Ablation Early Feasibility Study (EFS)
• Official Title: Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
• Brief Summary: This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
• Detailed Description: The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Thermedical SERF Ablation System and Durablate Catheter

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Ventricular Tachycardia
• Arrythmia
• Heart Diseases
• Cardiovascular Diseases

Intervention

Device: Saline Enhanced Radiofrequency (SERF) ablation

Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Other Name: Durablate Catheter and Thermedical Ablation System

Study Arms

Experimental: single arm

Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Intervention: Device: Saline Enhanced Radiofrequency (SERF) ablation

• Publications *: Packer DL, Wilber DJ, Kapa S, Dyrda K, Nault I, Killu AM, Kanagasundram A, Richardson T, Stevenson W, Verma A, Curley M; SERF Investigators. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010347. doi: 10.1161/CIRCEP.121.010347. Epub 2022 Jul 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2022): 16
• Original Estimated Enrollment (submitted: August 8, 2018): 20
• Actual Study Completion Date: July 31, 2022
• Actual Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subject has sustained, monomorphic VT
2. Subject has recurrent, symptomatic VT
3. Subject has drug refractory or drug intolerant sustained VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
4. ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that is suspected to be the same VT as initially targeted in a prior ablation
5. Subject has minimum 3-month ICD interrogation history available for evaluation
6. Subject has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
7. Subject is at least 18 years old
8. Subject has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

EXCLUSION CRITERIA:

1. Subjects with VT of idiopathic origin
2. Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin
3. Subjects with VTs of septal origin require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system; Subjects requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk
4. Subject with myocardial infarction (MI) or unstable angina within previous 60 days
5. Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
6. Subject with class IV (NYHA) heart failure
7. Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve
8. Subject with left ventricular assist device planned or required for the procedure
9. Subjects with co-morbidities such that they have less than 1-year life expectancy
10. Subject with evidence of intracardiac and/or laminated thrombus (in the left atrium including left atrial appendage or the left ventricle) evident by cardiac CT or transesophageal echo (TEE) and transthoracic echo (TTE) (with contrast if indicated) within 48 hours prior to ablation procedure
11. Subject with thrombocytopenia or other coagulopathy
12. Women who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
13. Subject with other acute illness or active systemic infection (unrelated to VT or its origin)
14. Significant congenital heart disease or cardiac anomaly
15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
16. Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT03628534
• Other Study ID Numbers: CP-100; 1R44HL132746-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thermedical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Thermedical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Douglas Packer, MD; Mayo Clinic

• PRS Account: Thermedical, Inc.
• Verification Date: August 2022