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Sponsored by: |
Maquet Cardiovascular |
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Information provided by: | Maquet Cardiovascular |
ClinicalTrials.gov Identifier: | NCT00415558 |
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS) procedure in approximately 30 patients at 6 investigational sites in the United States.
Condition | Intervention |
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Atrial Fibrillation |
Device: Microwave Ablation System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Multicenter, Un-Blinded, Single Arm, Clinical Study Using the Guidant Microwave Ablation System Comprised of the Flex 10 Ablation Probe and Microwave Generator for Patients With Symptomatic Paroxysmal Atrial Fibrillation |
Study Start Date: | May 2007 |
The study population for this study will be comprised of patients who have been diagnosed with symptomatic (PAF) for at least 6 months prior to study entry. Patients will be qualified for the study if they meet stringent inclusion/exclusion criteria, signing an informed consent and agreeing to return for followup visits at 1, 3, 6, 9 and 12 months. All study patients will receive microwave ablation to treat their symptomatic PAF. The Microwave Ablation System will be used during a MIS procedure on a beating heart in order to ablate a specified lesion pattern.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Mesa, Arizona, United States | |
United States, California | |
Long Beach, California, United States | |
Chico, California, United States | |
United States, Michigan | |
Saginaw, Michigan, United States | |
United States, Wisconsin | |
Madison, Wisconsin, United States |
Principal Investigator: | Li Poa, MD | Enloe Medical Center |
Principal Investigator: | Dudley Hudspeth, MD | Banner Desert Medical Center |
Principal Investigator: | Daniel Bethencourt, MD | Long Beach Memorial Medical Center |
Principal Investigator: | Niloo Edwards, MD | University of Wisconsin Hospitals and Clinics |
Principal Investigator: | Norbert Baumgartner, MD | Covenant Medical Center |
Responsible Party: | Maquet Cardiovascular ( Maquet Cardiovascular ) |
Study ID Numbers: | VR2049541 |
Study First Received: | December 20, 2006 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00415558 |
Health Authority: | United States: Food and Drug Administration |
Atrial Fibrillation |
Heart Diseases Atrial Fibrillation Cyclobenzaprine Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |