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
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Stroke
Interventions: Device: WATCHMAN Left Atrial Appendage Closure Technology
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Roll-in Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
WATCHMAN Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
WARFARIN Randomized to receive Warfarin control

Participant Flow:   Overall Study
    Roll-in     WATCHMAN     WARFARIN  
STARTED     93     463 [1]   244  
COMPLETED     67     299     133  
NOT COMPLETED     26     164     111  
Death                 5                 60                 44  
Withdrawal by Subject                 3                 18                 44  
Lost to Follow-up                 2                 22                 13  
Physician Decision                 0                 3                 10  
Device not implanted                 16                 61                 0  
[1] 2:1 randomization WATCHMAN to warfarin



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
2:1 randomazation, outcome analysis excludes the 93 subjects in the Roll-in arm

Reporting Groups
  Description
WATCHMAN WATCHMAN Left Atrial Appendage Closure Technology:
Warfarin Control Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Roll-in Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
Total Total of all reporting groups

Baseline Measures
    WATCHMAN     Warfarin Control     Roll-in     Total  
Number of Participants  
[units: participants]
  463     244     93     800  
Age  
[units: years]
Mean (Standard Deviation)
  71.7  (8.8)     72.7  (9.2)     72.2  (8.9)     72.0  (8.9)  
Gender  
[units: participants]
       
Female     137     73     28     238  
Male     326     171     65     562  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     4     1     0     5  
Black/African American     6     5     3     14  
Caucasian     425     222     87     734  
Hispanic/Latino     25     15     3     43  
Hawaiian/Pacific Islander     1     1     0     2  
other     2     0     0     2  
Region of Enrollment  
[units: participants]
       
United States     382     201     87     670  
Czech Republic     19     10     3     32  
Germany     62     33     3     98  



  Outcome Measures
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1.  Primary:   Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death   [ Time Frame: 5 years ]

2.  Primary:   The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events   [ Time Frame: 5 years ]

3.  Secondary:   Procedure Success   [ Time Frame: Initial implant procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Watchman Trial Manager
Organization: Boston Scientific
phone: 1-800-227-3422


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:


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