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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Atrial Fibrillation
Stroke
Interventions Device: WATCHMAN Left Atrial Appendage Closure Technology
Drug: Warfarin
Enrollment 800
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Roll-in WATCHMAN WARFARIN
Hide Arm/Group Description Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology Randomized to receive Warfarin control
Period Title: Overall Study
Started 93 463 [1] 244
Completed 67 299 133
Not Completed 26 164 111
Reason Not Completed
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
Arm/Group Title WATCHMAN Warfarin Control Roll-in Total
Hide Arm/Group Description WATCHMAN Left Atrial Appendage Closure Technology: Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis Total of all reporting groups
Overall Number of Baseline Participants 463 244 93 800
Hide Baseline Analysis Population Description
2:1 randomazation, outcome analysis excludes the 93 subjects in the Roll-in arm
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 463 participants 244 participants 93 participants 800 participants
71.7  (8.8) 72.7  (9.2) 72.2  (8.9) 72.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 463 participants 244 participants 93 participants 800 participants
Female
137
  29.6%
73
  29.9%
28
  30.1%
238
  29.8%
Male
326
  70.4%
171
  70.1%
65
  69.9%
562
  70.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 463 participants 244 participants 93 participants 800 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 463 participants 244 participants 93 participants 800 participants
United States 382 201 87 670
Czech Republic 19 10 3 32
Germany 62 33 3 98
1.Primary Outcome
Title Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
Hide Description 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)
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description

event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics

Roll-in subjects were not included in the primary outcome analysis per study design.

Arm/Group Title Implantable Device Warfarin Control
Hide Arm/Group Description:

Implantable WATCHMAN Left ATrial Appendage Occlusion Device

WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology

Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Warfarin: Subjects receive warfarin

Overall Number of Participants Analyzed 463 244
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 100 pt yrs
2.2
(1.7 to 3.1)
3.7
(2.4 to 4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Implantable Device, Warfarin Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.42 to 1.07
Estimation Comments Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals
2.Primary Outcome
Title The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
Hide Description 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.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description

Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics

Roll-in subjects were not included in the primary outcome analysis per study design.

Arm/Group Title Implantable Device Warfarin Control
Hide Arm/Group Description:

Implantable WATCHMAN Left ATrial Appendage Occlusion Device

WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology

Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Warfarin: Subjects receive warfarin

Overall Number of Participants Analyzed 463 244
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 pt-yrs
3.5
(2.7 to 4.5)
3.2
(2.1 to 4.4)
3.Secondary Outcome
Title Procedure Success
Hide Description Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Time Frame Initial implant procedure
Hide Outcome Measure Data
Hide Analysis Population Description
14 subjects did not have an implant procedure attempted
Arm/Group Title WATCHMAN
Hide Arm/Group Description:

Implantable WATCHMAN Left ATrial Appendage Occlusion Device

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Overall Number of Participants Analyzed 449
Measure Type: Number
Unit of Measure: percentage of implant attempts
90.9
Time Frame 5 years
Adverse Event Reporting Description electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
 
Arm/Group Title Roll-in WATCHMAN WARFARIN
Hide Arm/Group Description Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase Randomized to receive implantation of the WATCHMAN LAA closure Device Randomized to receive Warfarin control
All-Cause Mortality
Roll-in WATCHMAN WARFARIN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Roll-in WATCHMAN WARFARIN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/93 (31.18%)      143/463 (30.89%)      70/244 (28.69%)    
Blood and lymphatic system disorders       
Anemia Requiring Transfusion   0/93 (0.00%)  0 2/463 (0.43%)  2 1/244 (0.41%)  4
Device Thrombus   0/93 (0.00%)  0 2/463 (0.43%)  2 0/244 (0.00%)  0
Systemic Embolization   0/93 (0.00%)  0 3/463 (0.65%)  3 0/244 (0.00%)  0
Cardiac disorders       
Arrhythmias   0/93 (0.00%)  0 2/463 (0.43%)  2 0/244 (0.00%)  0
Cardiac Perforation   1/93 (1.08%)  1 7/463 (1.51%)  7 0/244 (0.00%)  0
Pericardial Effusion with Cardiac Tamponade   4/93 (4.30%)  4 13/463 (2.81%)  13 0/244 (0.00%)  0
Pericardial Effusion-Serious   0/93 (0.00%)  0 4/463 (0.86%)  4 0/244 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal Bleeding   9/93 (9.68%)  12 26/463 (5.62%)  32 22/244 (9.02%)  27
Oral Bleeding   0/93 (0.00%)  0 0/463 (0.00%)  0 1/244 (0.41%)  1
Rectal Bleeding   1/93 (1.08%)  1 1/463 (0.22%)  1 1/244 (0.41%)  1
General disorders       
Death   5/93 (5.38%)  5 59/463 (12.74%)  59 44/244 (18.03%)  44
Infections and infestations       
Infection   1/93 (1.08%)  1 2/463 (0.43%)  2 0/244 (0.00%)  0
Investigations       
Device Embolization   0/93 (0.00%)  0 3/463 (0.65%)  4 0/244 (0.00%)  0
Other Study Related   4/93 (4.30%)  4 17/463 (3.67%)  18 2/244 (0.82%)  2
Nervous system disorders       
Stroke - Hemorrhagic   0/93 (0.00%)  0 3/463 (0.65%)  3 10/244 (4.10%)  10
Stroke - Ischemic   5/93 (5.38%)  5 24/463 (5.18%)  26 10/244 (4.10%)  11
Transient Ischemic Attack (TIA)   1/93 (1.08%)  1 5/463 (1.08%)  5 0/244 (0.00%)  0
Renal and urinary disorders       
Hematuria   0/93 (0.00%)  0 4/463 (0.86%)  4 0/244 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Pulmonary Edema   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Vascular disorders       
AV Fistula   1/93 (1.08%)  1 1/463 (0.22%)  1 0/244 (0.00%)  0
Bleeding from Varicose Veins   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Bruising - Hematoma   2/93 (2.15%)  2 5/463 (1.08%)  5 0/244 (0.00%)  0
Cranial Bleed   1/93 (1.08%)  1 4/463 (0.86%)  4 1/244 (0.41%)  1
Epistaxis   2/93 (2.15%)  2 4/463 (0.86%)  4 0/244 (0.00%)  0
Major Bleed Requiring Transfusion   1/93 (1.08%)  1 2/463 (0.43%)  2 1/244 (0.41%)  1
Pseudoaneurysm   0/93 (0.00%)  0 3/463 (0.65%)  3 0/244 (0.00%)  0
Thrombosis   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Roll-in WATCHMAN WARFARIN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/93 (20.43%)      71/463 (15.33%)      17/244 (6.97%)    
Blood and lymphatic system disorders       
Anemia Requiring Transfusion   0/93 (0.00%)  0 2/463 (0.43%)  2 1/244 (0.41%)  1
Cardiac disorders       
Pericardial Effusion   3/93 (3.23%)  3 10/463 (2.16%)  10 0/244 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal Bleeding   1/93 (1.08%)  1 3/463 (0.65%)  3 2/244 (0.82%)  2
Oral Bleeding   0/93 (0.00%)  0 2/463 (0.43%)  2 1/244 (0.41%)  1
Rectal Bleeding   1/93 (1.08%)  1 3/463 (0.65%)  5 5/244 (2.05%)  5
General disorders       
Other Non-Study Related   0/93 (0.00%)  0 2/463 (0.43%)  2 0/244 (0.00%)  0
Immune system disorders       
Allergic Reaction to Contrast Media   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Infections and infestations       
Infection   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Injury, poisoning and procedural complications       
Air Embolism   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Inability to Move or Retrieve Device   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Investigations       
Device Thrombus   2/93 (2.15%)  2 14/463 (3.02%)  15 0/244 (0.00%)  0
Other Study Related   9/93 (9.68%)  9 19/463 (4.10%)  20 2/244 (0.82%)  2
Nervous system disorders       
Stroke - Ischemic   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Transient Ischemic Attack (TIA)   1/93 (1.08%)  1 2/463 (0.43%)  2 0/244 (0.00%)  0
Vasovagal Reactions   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Renal and urinary disorders       
Hematuria   0/93 (0.00%)  0 2/463 (0.43%)  2 2/244 (0.82%)  2
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Vascular disorders       
AV Fistula   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Bleeding from Varicose Veins   0/93 (0.00%)  0 1/463 (0.22%)  1 0/244 (0.00%)  0
Bruising - Hematoma   0/93 (0.00%)  0 3/463 (0.65%)  3 2/244 (0.82%)  2
Epistaxis   4/93 (4.30%)  4 11/463 (2.38%)  13 5/244 (2.05%)  5
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Watchman Trial Manager
Organization: Boston Scientific
Phone: 1-800-227-3422
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00129545    
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