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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129545
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE August 10, 2005
First Posted Date  ICMJE August 12, 2005
Results First Submitted Date  ICMJE October 3, 2014
Results First Posted Date  ICMJE May 15, 2015
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE February 2005
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
  • Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death [ Time Frame: 5 years ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
  • All stroke
  • Systemic embolism
  • Cardiovascular death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
Procedure Success [ Time Frame: Initial implant procedure ]
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
  • Technical success
  • Procedure Success
  • 30 day MAE
  • LAA Coverage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Official Title  ICMJE WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2015)
800
Original Enrollment  ICMJE
 (submitted: August 10, 2005)
200
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129545
Other Study ID Numbers  ICMJE ST1021 and ST1055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Holmes, MD Mayo Clinic
PRS Account Boston Scientific Corporation
Verification Date April 2015

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