SERF VT Ablation Early Feasibility Study (EFS)

NCT ID: NCT03628534

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-07-31

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.

Conditions

Ventricular Tachycardia; Arrythmia; Heart Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

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

Group Type: EXPERIMENTAL

Saline Enhanced Radiofrequency (SERF) ablation

Intervention Type: DEVICE

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

Interventions

Saline Enhanced Radiofrequency (SERF) ablation

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

Intervention Type: DEVICE

Other Intervention Names

Durablate Catheter and Thermedical Ablation System

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Thermedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Packer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Vanderbilt Heart

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 35776711 (View on PubMed)

Other Identifiers

1R44HL132746-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CP-100

Identifier Type: -

Identifier Source: org_study_id