Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
AtriCure, Inc. |
---|---|
Information provided by: | AtriCure, Inc. |
ClinicalTrials.gov Identifier: | NCT00566787 |
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multi-Center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery |
Enrollment: | 39 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | May 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:
Exclusion Criteria:
United States, Indiana | |
Heart Center of Indiana | |
Indianapolis, Indiana, United States, 46290 | |
United States, Michigan | |
Spectrum Health | |
Grand Rapids, Michigan, United States, 49506 | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Sentara Norfolk Hospital | |
Norfolk, Virginia, United States, 23507 | |
United States, Washington | |
Sacred Heart Medical Center | |
Seattle, Washington, United States, 99220 | |
United States, Wisconsin | |
St. Mary's Hospital Medical Center | |
Madison, Wisconsin, United States, 53715 |
Principal Investigator: | A. Marc Gillinov, MD | The Cleveland Clinic |
Responsible Party: | AtriCure, Inc. ( Jim Lucky ) |
Study ID Numbers: | CP2003-1 |
Study First Received: | December 3, 2007 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00566787 |
Health Authority: | United States: Food and Drug Administration |
AF Atrial Fibrillation afib racing heart cabg |
valve ablation bipolar radiofrequency rf |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |