SERF VT Ablation Early Feasibility Study (EFS)

NCT03628534 | Completed DMC FDA Device

• 2 other identifiers: CP-1001R44HL132746-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventricular Tachycardia; Arrythmia; Heart Diseases; Cardiovascular Diseases

Keywords

Cardiac Arrhythmia; Ventricular Tachycardia; Arrhythmia; Pathological processes

Outcome Measures

Primary Outcomes (2)

• EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure.

  Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success).

  By the end of the procedure

• SAFETY: SAEs that are probably or definitely device related within 30 days

  within 30 days

Study Arms (1)

single arm

EXPERIMENTAL

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

Device: Saline Enhanced Radiofrequency (SERF) ablation

Interventions

Saline Enhanced Radiofrequency (SERF) ablation DEVICE

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

Also known as: Durablate Catheter and Thermedical Ablation System

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has sustained, monomorphic VT
• Subject has recurrent, symptomatic VT
• 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
• 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
• Subject has minimum 3-month ICD interrogation history available for evaluation
• Subject has LVEF \> 20%, confirmed by echo or comparable technique during baseline evaluation
• Subject is at least 18 years old
• Subject has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

You may not qualify if:

• Subjects with VT of idiopathic origin
• Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin
• 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
• Subject with myocardial infarction (MI) or unstable angina within previous 60 days
• Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
• Subject with class IV (NYHA) heart failure
• Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve
• Subject with left ventricular assist device planned or required for the procedure
• Subjects with co-morbidities such that they have less than 1-year life expectancy
• 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
• Subject with thrombocytopenia or other coagulopathy
• Women who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
• Subject with other acute illness or active systemic infection (unrelated to VT or its origin)
• Significant congenital heart disease or cardiac anomaly
• Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.

Sponsors & Collaborators

• Thermedical, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Vanderbilt Heart

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 35776711 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Condition Hierarchy (Ancestors)

Tachycardia; Cardiac Conduction System Disease; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Packer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Thermedical SERF Ablation System and Durablate Catheter

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 14, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (3)