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| Sponsor: | AtriCure, Inc. |
|---|---|
| Information provided by (Responsible Party): | AtriCure, Inc. |
| ClinicalTrials.gov Identifier: | NCT00560885 |
Purpose
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Device: AtriCure Bipolar System |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery |
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Mercy Heart Institute | |
| Sacramento, California, United States, 95819 | |
| Sutter Health | |
| Sacramento, California, United States, 95819 | |
| United States, Indiana | |
| Heart Center of Indiana | |
| Indianapolis, Indiana, United States, 46290 | |
| United States, Michigan | |
| Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Texas | |
| Baylor Heart Hospital | |
| Dallas, Texas, United States, 75230 | |
| United States, Virginia | |
| Inova Fairfax | |
| Falls Church, Virginia, United States, 22042 | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
More Information
| Responsible Party: | AtriCure, Inc. |
| ClinicalTrials.gov Identifier: | NCT00560885 History of Changes |
| Other Study ID Numbers: | CP2007-1 |
| Study First Received: | November 19, 2007 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
atrial fibrillation af ablation arrhythmia |
racing heart afib surgical ablation |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |