CardioFocus ENABLE Investigational Clinical Study

ENdoscopic ABlation using Light Energy

This FDA-approved study is designed to assess the safety and efficacy of an investigational device for the treatment of paroxysmal atrial fibrillation (AF). As an investigational device, the EAS is only offered through this clinical study and is not commercially available. Up to 25 U.S. clinical sites will participate in the study.

The purpose of the study is to compare two types of treatment for PAF that are designed to treat the symptoms of AF. The treatments being compared are:

A single catheter ablation with the investigational EAS, a visually-guided, light-energy catheter
Standard drug therapy (antiarrhythmic drugs)

To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you from the list below. Check back frequently for additional investigation sites.

Eligibility Criteria

Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:

18 to 80 years of age
Frequent episodes of AF
Failed at least 1 drug treatment for AF
Other criteria

View an EAS animation by clicking here.

Clinical Study Center	Location	Principal Investigator and Contact
St. John’s Health Center	Santa Monica, CA	Shephal Doshi, MD Lissa Dela Cruz, CRC 310-829-7678 e-mail news clinician tutorial study brochure
Florida Hospital	Orlando, FL	Scott Pollak, MD Leann Goodwin, RN 407-303-8059 e-mail news video clinician tutorial screening announcement study brochure prequalification screener
St. Luke’s-Roosevelt Hospital Center	New York, NY	Jonathan Steinberg, MD Robin Knox, RN 212-523-3253 e-mail news clinician tutorial screening announcement prequalification screener
William Beaumont Hospital	Royal Oak, MI	David E. Haines, MD Sue Buck, RN 248-898-5589 e-mail news clinician tutorial screening announcement study brochure prequalification screener
University of Virginia	Charlottesville, VA	J. Michael Mangrum, MD Mary Jane Strickland 434-982-6401 e-mail news clinician tutorial screening announcement study brochure prequalification screener
The Methodist Hospital Research Institute	Houston, TX	Miguel Valderrábano, MD Christine Sasaridis 713-441-3671 e-mail news clinician tutorial screening announcement study brochure prequalification screener
Indiana University Krannert Institute of Cardiology	Indianapolis, IN	John Miller, MD Susan Straka, RN 317-962-0073 e-mail clinician tutorial
Ohio State University	Columbus, OH	Emile Daoud, MD Kathryn Crow, RN 614-247-7734 e-mail clinician tutorial prequalification screener
University of Pennsylvania Hospital	Philadelphia, PA	Edward Gerstenfeld, MD Marty Sweeney, RN 215-615-0186 e-mail clinician tutorial screening announcement study brochure prequalification screener
University of Rochester Medical Center	Rochester, NY	James Daubert, MD Colleen Patterson 585-273-5247 e-mail clinician tutorial screening announcement study brochure prequalification screener
Texas Cardiac Arrhythmia Institute	Austin, TX	Rodney P. Horton, MD Chantel Scallon, RN 512-441-1980 ext 1340 e-mail clinician tutorial study brochure
Arizona Arrhythmia Research Center	Scottsdale, AZ	Vijendra Swarup, MD Peeyush Khanna, Ph.D. 602-234-2800 ext 3085 e-mail clinician tutorial study brochure
University of Michigan	Ann Arbor, MI	Eric D. Good, DO Jacqueline Fortino, RN 734-615-2680 e-mail clinician tutorial study brochure
University of California San Francisco	San Francisco, CA	Nitish Badhwar, MD Patricia Malone, RN 415-514-0334 e-mail clinician tutorial
Sentara Cardiovascular Research Institute	Norfolk, VA	John R. Onufer, MD Denise Karch, RN, BSN 757-388-5408 e-mail clinician tutorial
Genesis Medical Center	Davenport, IA	Michael Giudici, MD Caroline Sloane, RN, BS 757-388-5408 e-mail clinician tutorial

Disclaimer

The U.S. Food and Drug Administration (FDA) has not approved the Endoscopic Ablation System for general use.
The EAS is an investigational device in the United States, and is under IDE status (Investigational Device Exemption). In the United States, this investigational product can only be used in pre-marketing clinical studies approved by the FDA. For further information, please contact CardioFocus, Inc.
This web site is intended to comply with U.S. laws and regulations. While accessible to users outside of the U.S., the information on this web site is intended for use only by residents of the U.S.