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 Closure Technology	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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 [ Time Frame: 45 days ] [ Designated as safety issue: No ]
Procedure success [ Time Frame: 45 days ] [ 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 [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	1550
Study Start Date:	February 2005
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Other Name: WATCHMAN

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

Show 62 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 ClinicalTrials.gov Identifier (NCT Number):

Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. Epub 2011 Jan 17.

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:	Lisa Ingham - Director of Clinical Affairs, Atritech, Inc.
ClinicalTrials.gov Identifier:	NCT00129545 History of Changes
Other Study ID Numbers:	ST1021 and ST1055
Study First Received:	August 10, 2005
Last Updated:	June 15, 2011
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:

Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2012