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

August 10, 2005
September 23, 2013
February 2005
August 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • All stroke
  • Systemic embolism
  • Cardiovascular death
Complete list of historical versions of study NCT00129545 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Technical success
  • Procedure success
  • 30 day MAE
  • LAA Coverage
Not Provided
Not Provided
 
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Stroke
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN
Experimental: Implantable device
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
Intervention: Device: WATCHMAN Left Atrial Appendage Closure Technology

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1550
January 2014
August 2013   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Germany
 
NCT00129545
ST1021 and ST1055
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: David Holmes, MD Mayo Clinic
Boston Scientific Corporation
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP