WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation - Full Text View

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)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

U.S. FDA Resources

Further study details as provided by Atritech:

Primary Outcome Measures:

All stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Systemic embolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Cardiovascular death [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Technical success [ Designated as safety issue: No ]
Procedure success [ Designated as safety issue: No ]
30 day major adverse event (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Left atrial appendage (LAA) coverage [ Designated as safety issue: No ]

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)

Detailed Description:

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

Criteria

Inclusion Criteria:

Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
Eligible for long term warfarin
CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])

Exclusion Criteria:

Contraindicated for warfarin
Contraindicated for aspirin or clopidogrel (Plavix)
CHF Class 4
Implanted mechanical valve
Atrial septal or Patent Foramen Ovale (PFO) device
Platelets < 100,000 or hemoglobin < 10
Left ventricular ejection fraction (LVEF) < 30%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129545

Contacts

Contact: Andrea Stone, BS	763.746.5005	astone@atritech.net
Contact: Lisa Ingham, BS	763.746.5070	lingham@atritech.net

Show 51 Study Locations

Sponsors and Collaborators

Atritech

Investigators

Principal Investigator:

David Holmes, MD

Mayo Clinic

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

No publications provided by Atritech

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42.

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

Keywords provided by Atritech:

Atrial Fibrillation
AF
A Fib
Stroke
Coumadin
Warfarin

Blood thinning medication
TIA
WATCHMAN
Left atrial appendage
LAA isolation
LAA occlusion

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Atrial Fibrillation
Brain Diseases
Cerebrovascular Disorders
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010