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WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Atritech
ClinicalTrials.gov Identifier:
NCT00129545
First received: August 10, 2005
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  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:

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:
    Device: WATCHMAN Left Atrial Appendage Closure Technology
    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):

Responsible Party: Atritech
ClinicalTrials.gov Identifier: NCT00129545     History of Changes
Other Study ID Numbers: ST1021 and ST1055
Study First Received: August 10, 2005
Last Updated: August 1, 2012
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 16, 2013