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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00129545
First received: August 10, 2005
Last updated: April 29, 2015
Last verified: April 2015

August 10, 2005
April 29, 2015
February 2005
August 2013   (final data collection date for primary outcome measure)
  • Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)
  • The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
  • Cardiovascular death
  • All stroke
  • Systemic embolism
Complete list of historical versions of study NCT00129545 on ClinicalTrials.gov Archive Site
Procedure Success [ Time Frame: Initial implant procedure ] [ Designated as safety issue: No ]
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
  • 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: Parallel 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
  • Drug: Warfarin
    Subjects receive warfarin
    Other Name: Coumadin
  • Experimental: WATCHMAN
    Implant of WATCHMAN Left Atrial Appendage Closure Technology
    Intervention: Device: WATCHMAN Left Atrial Appendage Closure Technology
  • Active Comparator: Warfarin control
    Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
    Intervention: Drug: Warfarin
  • Roll-in
    Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
    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.
 
Completed
800
May 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)
  • Congestive heart failure (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
April 2015

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