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Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS) (SERF VT EFS)

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ClinicalTrials.gov Identifier: NCT03628534
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Thermedical, Inc.

Brief Summary:
The primary objective is to demonstrate safety and feasibility of the Thermedical Ablation System and Durablate needle catheter in subjects with recurrent, monomorphic ventricular tachycardia (VT) who have failed conventional treatment.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Arrythmia Heart Diseases Cardiovascular Diseases Device: Saline Enhanced Radiofrequency (SERF) ablation Not Applicable

Detailed Description:
The purpose of this study is to gather information on the safety and effectiveness of a new 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm
Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
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




Primary Outcome Measures :
  1. 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).

  2. SAFETY: Serious adverse events that are probably or definitely device related related [ Time Frame: within 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 significant intracardiac and/or laminated thrombus evident by transesophageal echo (TEE) or transthoracic echo (TTE) (with contrast) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628534


Contacts
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Contact: Trena Depel 7813733688 t.depel@thermedical.com

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jean Del Priore, RN    708-216-2644    jdelpri@luc.edu   
Principal Investigator: David Wilber, Dr.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kristi Monahan    507-255-6676    Monahan.Kristi@mayo.edu   
Principal Investigator: Douglas Packer, Dr.         
United States, Tennessee
Vanderbilt Heart Recruiting
Nashville, Tennessee, United States, 37232
Contact: John A Viselli    615-936-5023    John.a.viselli@vumc.org   
Principal Investigator: William Stevenson, MD         
Sponsors and Collaborators
Thermedical, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Douglas Packer, Dr. Mayo Clinic
Principal Investigator: David Wilber, Dr. Loyola University

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Responsible Party: Thermedical, Inc.
ClinicalTrials.gov Identifier: NCT03628534     History of Changes
Other Study ID Numbers: CP-100
R44HL132746 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Thermedical, Inc.:
Cardiac Arrhythmia
Ventricular Tachycardia
Arrhythmia
Pathological processes
Additional relevant MeSH terms:
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Heart Diseases
Tachycardia
Tachycardia, Ventricular
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes