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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):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00129545
First received: August 10, 2005
Last updated: September 23, 2013
Last verified: September 2013
  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:


Further study details as provided by Boston Scientific Corporation:

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: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantable device
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 62 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David Holmes, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00129545     History of Changes
Other Study ID Numbers: ST1021 and ST1055
Study First Received: August 10, 2005
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014