Trial Outcomes & Findings for Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology (NCT NCT01760291)
NCT ID: NCT01760291
Last Updated: 2022-03-29
Results Overview
Primary Endpoint Events by Type for Enrolled Subjects
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
576 participants
Primary outcome timeframe
5 Year Follow Up
Results posted on
2022-03-29
Participant Flow
Participant milestones
| Measure |
WATCHMAN
WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology
|
|---|---|
|
Overall Study
STARTED
|
576
|
|
Overall Study
COMPLETED
|
340
|
|
Overall Study
NOT COMPLETED
|
236
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology
Baseline characteristics by cohort
| Measure |
WATCHMAN
n=576 Participants
WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology
|
|---|---|
|
Age, Continuous
|
75.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
349 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
542 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
576 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 Year Follow UpPrimary Endpoint Events by Type for Enrolled Subjects
Outcome measures
| Measure |
WATCHMAN
n=576 Participants
WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology
|
|---|---|
|
Number of Participants With Ischemic Stroke
|
47 Participants
|
Adverse Events
WATCHMAN
Serious events: 84 serious events
Other events: 16 other events
Deaths: 144 deaths
Serious adverse events
| Measure |
WATCHMAN
n=576 participants at risk
WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology
|
|---|---|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
1.0%
6/576 • Number of events 6 • 5 years
|
|
General disorders
Anemia Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Anemia Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Anemia Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Arrhythmias
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Bleeding from Varicose Veins
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Bleeding, Other
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Cardiac disorders
Cardiac Perforation
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Cranial Bleed
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Nervous system disorders
Cranial Bleed
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Death - Non-Cardiovascular
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Death - Non-Cardiovascular
|
1.9%
11/576 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
Death - Non-Cardiovascular
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
General disorders
Death - Non-Cardiovascular
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Infections and infestations
Death - Non-Cardiovascular
|
2.1%
12/576 • Number of events 12 • 5 years
|
|
Injury, poisoning and procedural complications
Death - Non-Cardiovascular
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Non-Cardiovascular
|
1.9%
11/576 • Number of events 11 • 5 years
|
|
Nervous system disorders
Death - Non-Cardiovascular
|
1.4%
8/576 • Number of events 8 • 5 years
|
|
Renal and urinary disorders
Death - Non-Cardiovascular
|
0.87%
5/576 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Death - Non-Cardiovascular
|
3.1%
18/576 • Number of events 18 • 5 years
|
|
Vascular disorders
Death - Non-Cardiovascular
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Cardiac disorders
Death- Cardiovascular/Unexplained
|
6.4%
37/576 • Number of events 37 • 5 years
|
|
General disorders
Death- Cardiovascular/Unexplained
|
2.1%
12/576 • Number of events 12 • 5 years
|
|
Infections and infestations
Death- Cardiovascular/Unexplained
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death- Cardiovascular/Unexplained
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Nervous system disorders
Death- Cardiovascular/Unexplained
|
1.0%
6/576 • Number of events 6 • 5 years
|
|
Renal and urinary disorders
Death- Cardiovascular/Unexplained
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Death- Cardiovascular/Unexplained
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Vascular disorders
Death- Cardiovascular/Unexplained
|
0.87%
5/576 • Number of events 5 • 5 years
|
|
Vascular disorders
Device Thrombus (thrombus on the atrial facing side of the device)
|
0.87%
5/576 • Number of events 6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Gastrointestinal Bleeding
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
3.0%
17/576 • Number of events 17 • 5 years
|
|
Vascular disorders
Gastrointestinal Bleeding
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
0.87%
5/576 • Number of events 6 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.87%
5/576 • Number of events 6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Infection
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Major Bleed Requiring Transfusion
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Major Bleed Requiring Transfusion
|
1.2%
7/576 • Number of events 7 • 5 years
|
|
Injury, poisoning and procedural complications
Major Bleed Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Major Bleed Requiring Transfusion
|
3.3%
19/576 • Number of events 22 • 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Vascular disorders
Myocardial Infarction
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Oral Bleeding
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oral Bleeding
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Other (Non-Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Other (Non-Study Related)
|
1.9%
11/576 • Number of events 11 • 5 years
|
|
General disorders
Other (Non-Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Infections and infestations
Other (Non-Study Related)
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Other (Non-Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other (Non-Study Related)
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Nervous system disorders
Other (Non-Study Related)
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Renal and urinary disorders
Other (Non-Study Related)
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Other (Non-Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Other (Non-Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
General disorders
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Nervous system disorders
Other (Study Related)
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Other (Study Related)
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Other (Study Related)
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Cardiac disorders
Pericardial Effusion with Cardiac Tamponade
|
1.4%
8/576 • Number of events 8 • 5 years
|
|
Vascular disorders
Pseudoaneurysm
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Cardiac disorders
Respiratory Failure
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Infections and infestations
Respiratory Failure
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.0%
17/576 • Number of events 17 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Nervous system disorders
Stroke (Hemorrhagic)
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Nervous system disorders
Stroke (Ischemic)
|
7.5%
43/576 • Number of events 48 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
1.0%
6/576 • Number of events 6 • 5 years
|
|
Nervous system disorders
Subdural Hematoma
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Subdural Hematoma
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Systemic Embolism
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Systemic Embolism
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Transient Ischemic Attack (TIA)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.2%
7/576 • Number of events 7 • 5 years
|
|
Nervous system disorders
Valvular Damage
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.35%
2/576 • Number of events 2 • 5 years
|
|
Nervous system disorders
Ventricular Fibrillation
|
0.17%
1/576 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
WATCHMAN
n=576 participants at risk
WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology
|
|---|---|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Anemia Requiring Transfusion
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Vascular disorders
Device Thrombus (thrombus on the atrial facing side of the device)
|
2.8%
16/576 • Number of events 19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
8/576 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.69%
4/576 • Number of events 4 • 5 years
|
|
General disorders
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Product Issues
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Other (Study Related)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.7%
10/576 • Number of events 10 • 5 years
|
|
Vascular disorders
Pseudoaneurysm
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Nervous system disorders
Stroke (Ischemic)
|
0.87%
5/576 • Number of events 5 • 5 years
|
|
Vascular disorders
Stroke (Ischemic)
|
0.17%
1/576 • Number of events 1 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.52%
3/576 • Number of events 3 • 5 years
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.17%
1/576 • Number of events 1 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place