Arrhythmia Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following Arrhythmia trials:
• CAP AF: Continued Access Protocol
• PROTECT AF: Left Atrial Appendage Occluder Device for Patients in Atrial Fibrillation
• STOP AF: A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
CAP AF: Continued Access Protocol
Principal Investigator: Walter Kerwin, MD
IRB Approval Number: 20314
Contact: Walter Kerwin, MD (310) 289-0141
Study Coordinator: Stacy Gerez (310) 275-9551
Status: Enrolling
Summary: This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
PROTECT AF: Left Atrial Appendage Occluder Device for Patients in Atrial Fibrillation
Principal Investigator: Saibal Kar, MD
Co-Investigator: Walter Kerwin, MD
IRB Approval Number: 6687
Contact: Diana Remba (310) 423-6586
Status: Enrolling
Summary: This pivotal study is designed to demonstrate the safety and effectiveness of the WATCHMAN implant in patients with non-valvular paroxysmal, persistent or permanent atrial fibrillation (AF) who require treatment for potential thrombus formation, are eligible for warfarin therapy, and have a CHADs stroke risk stratification score of 1 or greater. The WATCHMAN implant is implanted via a catheter-based delivery system under local sedation in a catheterization laboratory setting. The device is permanently implanted at or slightly distal to and spans the ostium of the left atrial appendage using a standard transseptal catheterization technique.
STOP AF: A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrilation
Principal Investigator: Walter Kerwin, MD
IRB Approval Number: 9098
Contact: Walter Kerwin, MD (310) 289-0141
Study Coordinator: Stacy Gerez (310) 275-9551
Status: Enrollment closed
Summary: PS-023 is a randomized controlled clinical study. The purpose of this study is to determine whether this new catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as to see if this treatment is better compared to a medication. This catheter system uses freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary veins. A refrigerant (cooling material) is delivered within the catheter to cool the catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor MAX, will be used to freeze that area. This experimental catheter also uses freezing to ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia called atrial flutter. In order to treat or to prevent atrial flutter after the procedure, the Freezor MAX catheter may be used to freeze the cells in the area of the heart where atrial flutter starts.
