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Sponsored by: |
Medtronic Cardiac Surgery |
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Information provided by: | Medtronic Cardiac Surgery |
ClinicalTrials.gov Identifier: | NCT00506493 |
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat persistent AF patients.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Device: Surgical RF Ablation utilizing the Cardioblate System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study |
Estimated Enrollment: | 75 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2012 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
Exclusion Criteria:
Contact: Kathy Fahey | 763-514-6645 | kathy.fahey@medtronic.com |
Contact: Eric Vang | 763-514-6655 | eric.vang@medtronic.com |
United States, Arizona | |
Southwest Heart and Lung | Recruiting |
Phoenix, Arizona, United States | |
Contact: JoAnne Saczynski, RN, MSN, CRC 408.323.3390 jsaczynski@shc.org | |
Contact: Martha Hatifield, RN, BSN, CCRC 408.323.3833 MHatfield@SHC.org | |
Principal Investigator: Michael Caskey, MD | |
Sub-Investigator: Kenneth Ashton | |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Becky Lopez, RN 323-442-6226 bmlopez@surgery.usc.edu | |
Principal Investigator: Vaughn A Starnes, MD | |
Sub-Investigator: Mark J Cunningham, MD | |
Sub-Investigator: Craig J. Baker, MD | |
Eisenhower Medical Center | Recruiting |
Palm Springs, California, United States, 92270 | |
Contact: Walter DeSha 760-568-4330 wdesha@emc.org | |
Contact: William Boyle 760.568.4330 wboyle@emc.org | |
Principal Investigator: Surin Mitruka, MD | |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Anna Huskin, , RN, BSN, CCRC (312) 695-4067 | |
Contact: Jane Kruse, RN, BSN 312.695.4665 jkruse@nmh.org | |
Sub-Investigator: Patrick M McCarthy, MD | |
Principal Investigator: Richard Lee, MD, MBA | |
United States, Minnesota | |
Mayo/St. Mary's Hospital | Recruiting |
Rochester, Minnesota, United States, 55902 | |
Contact: Deborah A Rolbiecki 507-266-8044 rolbiecki.deborah@mayo.edu | |
Principal Investigator: Thoralf Sundt, M.D | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States | |
Contact: Marcie Bailey, RN, MSN 314-747-1930 baileym@wustl.edu | |
Principal Investigator: Ralph Damiano, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States | |
Contact: Denise Kosty Sweeny 216-444-0758 sweened2@ccf.org | |
Contact: Pam Lackner (216) 445-4337 LACKNEP@ccf.org | |
Principal Investigator: A. Marc Gillinov, MD | |
Sub-Investigator: Tomislav Mihaljevic, MD | |
Sub-Investigator: Lars Svensson, MD | |
Sub-Investigator: Eric Roselli, MD | |
Sub-Investigator: Jose Navia, MD | |
Sub-Investigator: Gosta Pettersson, MD | |
Sub-Investigator: Nicholas Smedira, MD | |
United States, Pennsylvania | |
Hospital of University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States | |
Contact: Deb Dougherty, RN, BSN, CCRC 215-662-4806 deb.dougherty@uphs.upenn.edu | |
Principal Investigator: Michael Acker, MD | |
United States, Virginia | |
Inova Fairfax | Not yet recruiting |
Falls Church, Virginia, United States, 22042 | |
Contact: Vivianna Aristizabal 703-776-2645 var@rxtrialsinc.com | |
Contact: Kathy Pancoe, RN 703.776.2645 kep@rxtrialsinc.com | |
Principal Investigator: Niv Ad, MD | |
United States, Wisconsin | |
Aurora St. Luke's Medical Center | Recruiting |
Milwaukee, Wisconsin, United States, 53515 | |
Contact: Jennifer Cooper, RN, CNOR 414-385-2504 jennifer.cooper@aurora.org | |
Principal Investigator: David C Kress, MD |
Principal Investigator: | Ralph Damiano, MD | Washington University School of Medicine |
Principal Investigator: | A. Marc Gillinov, MD | The Cleveland Clinic |
Study ID Numbers: | CURE-AF/Persistent |
Study First Received: | July 22, 2007 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00506493 |
Health Authority: | United States: Food and Drug Administration |
Persistent Atrial Fibrillation Surgical RF Ablation Perisistent Atrial Fibrillation Surgical Ablation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |