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

Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:November 8, 2018
End Date:December 2019
Contact:Trena Depel

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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.

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.

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

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

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

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
We found this trial at
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: David Wilber, Dr.
Phone: 708-216-2644
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
Maywood, IL
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Rochester, Minnesota 55905
Principal Investigator: Douglas Packer, Dr.
Phone: 507-255-6676
Rochester, MN
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