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
  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
Drug: Warfarin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 800
Study Start Date: February 2005
Study Completion Date: May 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN
Active Comparator: Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Drug: Warfarin
Subjects receive warfarin
Other Name: Coumadin
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.
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)
  • 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%
  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
Results First Received: October 3, 2014
Last Updated: April 29, 2015
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
transient ischemic attack (TIA)
WATCHMAN
Left atrial appendage
LAA isolation
LAA occlusion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015