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. Identifier: NCT00129545
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Interventions: Device: WATCHMAN Left Atrial Appendage Closure Technology
Drug: Warfarin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 463   244   93   800 
[Units: Years]
Mean (Standard Deviation)
 71.7  (8.8)   72.7  (9.2)   72.2  (8.9)   72.0  (8.9) 
[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

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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation Identifier: NCT00129545     History of Changes
Other Study ID Numbers: ST1021 and ST1055
First Submitted: August 10, 2005
First Posted: August 12, 2005
Results First Submitted: October 3, 2014
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015