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| Sponsor: | Atritech |
|---|---|
| Information provided by: | Atritech |
| ClinicalTrials.gov Identifier: | NCT00129545 |
Purpose
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Stroke |
Device: WATCHMAN Left Atrial Appendage System |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) |
| Estimated Enrollment: | 1550 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrea Stone, BS | 763.746.5005 | astone@atritech.net |
| Contact: Lisa Ingham, BS | 763.746.5070 | lingham@atritech.net |
Show 51 Study Locations| Principal Investigator: | David Holmes, MD | Mayo Clinic |
More Information
| Responsible Party: | Atritech, Inc. ( Linn Laak VP of Regulatory/Clinical ) |
| Study ID Numbers: | ST1021 and ST1055 |
| Study First Received: | August 10, 2005 |
| Last Updated: | December 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00129545 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial Fibrillation AF A Fib Stroke Coumadin Warfarin |
Blood thinning medication TIA WATCHMAN Left atrial appendage LAA isolation LAA occlusion |
|
Pathologic Processes Heart Diseases Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Atrial Fibrillation Brain Diseases Cerebrovascular Disorders Arrhythmias, Cardiac |