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| Descriptive Information Fields | |||||||||
| Brief Title † | AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB | ||||||||
| Official Title † | Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation | ||||||||
| Brief Summary | Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF). |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||||||
| Primary Outcome Measure † | Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions. [ Time Frame: Perioperative ] [ Designated as safety issue: No ] The primary safety endpoint will be determined by assessing the rate of serious adverse events. [ Time Frame: Discharge/30 Days ] [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Atrial Fibrillation | ||||||||
| Intervention † | Device: AtriCure Bipolar System | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 25 | ||||||||
| Start Date † | July 2008 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00571779 | ||||||||
| Organization ID | CP2007-2 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | AtriCure, Inc. | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | AtriCure, Inc. | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | December 10, 2007 | ||||||||
| Last Updated Date | June 19, 2008 | ||||||||