Trial Outcomes & Findings for WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (NCT NCT00129545)
NCT ID: NCT00129545
Last Updated: 2015-05-15
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
800 participants
Primary outcome timeframe
5 years
Results posted on
2015-05-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
463
|
244
|
|
Overall Study
COMPLETED
|
67
|
299
|
133
|
|
Overall Study
NOT COMPLETED
|
26
|
164
|
111
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
60
|
44
|
|
Overall Study
Withdrawal by Subject
|
3
|
18
|
44
|
|
Overall Study
Lost to Follow-up
|
2
|
22
|
13
|
|
Overall Study
Physician Decision
|
0
|
3
|
10
|
|
Overall Study
Device not implanted
|
16
|
61
|
0
|
Baseline Characteristics
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
WATCHMAN
n=463 Participants
WATCHMAN Left Atrial Appendage Closure Technology:
|
Warfarin Control
n=244 Participants
Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
|
Roll-in
n=93 Participants
Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
72.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
326 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
425 participants
n=5 Participants
|
222 participants
n=7 Participants
|
87 participants
n=5 Participants
|
734 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
25 participants
n=5 Participants
|
15 participants
n=7 Participants
|
3 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
382 participants
n=5 Participants
|
201 participants
n=7 Participants
|
87 participants
n=5 Participants
|
670 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
3 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
62 participants
n=5 Participants
|
33 participants
n=7 Participants
|
3 participants
n=5 Participants
|
98 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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)
Outcome measures
| Measure |
Implantable Device
n=463 Participants
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology
|
Warfarin Control
n=244 Participants
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin: Subjects receive warfarin
|
|---|---|---|
|
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
|
2.2 events per 100 pt yrs
Interval 1.7 to 3.1
|
3.7 events per 100 pt yrs
Interval 2.4 to 4.8
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Implantable Device
n=463 Participants
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology
|
Warfarin Control
n=244 Participants
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin: Subjects receive warfarin
|
|---|---|---|
|
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
|
3.5 Events per 100 pt-yrs
Interval 2.7 to 4.5
|
3.2 Events per 100 pt-yrs
Interval 2.1 to 4.4
|
SECONDARY outcome
Timeframe: Initial implant procedurePopulation: 14 subjects did not have an implant procedure attempted
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Outcome measures
| Measure |
Implantable Device
n=449 Participants
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology
|
Warfarin Control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin: Subjects receive warfarin
|
|---|---|---|
|
Procedure Success
|
90.9 percentage of implant attempts
|
—
|
Adverse Events
Roll-in
Serious events: 29 serious events
Other events: 19 other events
Deaths: 0 deaths
WATCHMAN
Serious events: 143 serious events
Other events: 71 other events
Deaths: 0 deaths
WARFARIN
Serious events: 70 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Roll-in
n=93 participants at risk
Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
|
WATCHMAN
n=463 participants at risk
Randomized to receive implantation of the WATCHMAN LAA closure Device
|
WARFARIN
n=244 participants at risk
Randomized to receive Warfarin control
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Cardiac disorders
Arrhythmias
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
AV Fistula
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Bleeding from Varicose Veins
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Bruising - Hematoma
|
2.2%
2/93 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
1.1%
5/463 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Cardiac disorders
Cardiac Perforation
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
1.5%
7/463 • Number of events 7 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Cranial Bleed
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.86%
4/463 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
General disorders
Death
|
5.4%
5/93 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
12.7%
59/463 • Number of events 59 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
18.0%
44/244 • Number of events 44 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Investigations
Device Embolization
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Blood and lymphatic system disorders
Device Thrombus
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Epistaxis
|
2.2%
2/93 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.86%
4/463 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
9.7%
9/93 • Number of events 12 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
5.6%
26/463 • Number of events 32 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
9.0%
22/244 • Number of events 27 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.86%
4/463 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Infections and infestations
Infection
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Major Bleed Requiring Transfusion
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Oral Bleeding
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/463 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Investigations
Other Study Related
|
4.3%
4/93 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
3.7%
17/463 • Number of events 18 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.82%
2/244 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Cardiac disorders
Pericardial Effusion with Cardiac Tamponade
|
4.3%
4/93 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
2.8%
13/463 • Number of events 13 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Cardiac disorders
Pericardial Effusion-Serious
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.86%
4/463 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Rectal Bleeding
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Stroke - Hemorrhagic
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
4.1%
10/244 • Number of events 10 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Stroke - Ischemic
|
5.4%
5/93 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
5.2%
24/463 • Number of events 26 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
4.1%
10/244 • Number of events 11 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Blood and lymphatic system disorders
Systemic Embolization
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Thrombosis
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
1.1%
5/463 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
Other adverse events
| Measure |
Roll-in
n=93 participants at risk
Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
|
WATCHMAN
n=463 participants at risk
Randomized to receive implantation of the WATCHMAN LAA closure Device
|
WARFARIN
n=244 participants at risk
Randomized to receive Warfarin control
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Air Embolism
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Immune system disorders
Allergic Reaction to Contrast Media
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
AV Fistula
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Bleeding from Varicose Veins
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Bruising - Hematoma
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.82%
2/244 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Investigations
Device Thrombus
|
2.2%
2/93 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
3.0%
14/463 • Number of events 15 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Vascular disorders
Epistaxis
|
4.3%
4/93 • Number of events 4 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
2.4%
11/463 • Number of events 13 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
2.0%
5/244 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.82%
2/244 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.82%
2/244 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Injury, poisoning and procedural complications
Inability to Move or Retrieve Device
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Infections and infestations
Infection
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Oral Bleeding
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.41%
1/244 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
General disorders
Other Non-Study Related
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Investigations
Other Study Related
|
9.7%
9/93 • Number of events 9 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
4.1%
19/463 • Number of events 20 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.82%
2/244 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Cardiac disorders
Pericardial Effusion
|
3.2%
3/93 • Number of events 3 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
2.2%
10/463 • Number of events 10 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Gastrointestinal disorders
Rectal Bleeding
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.65%
3/463 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
2.0%
5/244 • Number of events 5 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Stroke - Ischemic
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.1%
1/93 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.43%
2/463 • Number of events 2 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
|
Nervous system disorders
Vasovagal Reactions
|
0.00%
0/93 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.22%
1/463 • Number of events 1 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
0.00%
0/244 • 5 years
electronic case report form (e-CRF) completion by sites, followed by independent Clinical Events Committee (CEC) adjudication
|
Additional Information
Watchman Trial Manager
Boston Scientific
Phone: 1-800-227-3422
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60