Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Arrythmia
- Cardiovascular Diseases
- Heart Diseases
- Ventricular Tachycardia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 medi...
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.
Tracking Information
- NCT #
- NCT03628534
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Douglas Packer, Dr. Mayo Clinic Principal Investigator: David Wilber, Dr. Loyola University
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