A Phase 2/3 interventional study of WATCHMAN Left Atrial Appendage Closure Technology and Warfarin in Atrial Fibrillation and Stroke, sponsored by Boston Scientific Corporation. Completed at 62 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-15.
Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Prevention
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 800 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Device: WATCHMAN Left Atrial Appendage Closure Technology
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Drug: Warfarin
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Also known as: WATCHMAN
Subjects receive warfarin
Also known as: Coumadin
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
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
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
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
Procedure Success
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Time frame: Initial implant procedure
| Milestone | Roll-in | WATCHMAN | WARFARIN |
|---|---|---|---|
| Started | 93 | 463 | 244 |
| Completed | 67 | 299 | 133 |
| Not completed | 26 | 164 | 111 |
| Withdrew: Death | 5 | 60 | 44 |
| Withdrew: Withdrawal by subject | 3 | 18 | 44 |
| Withdrew: Lost to follow-up | 2 | 22 | 13 |
| Withdrew: Physician decision | 0 | 3 | 10 |
| Withdrew: Device not implanted | 16 | 61 | 0 |
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)
| events per 100 pt yrs | Implantable Device | Warfarin Control |
|---|---|---|
| Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death | 2.2 (1.7 to 3.1) | 3.7 (2.4 to 4.8) |
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.
| Events per 100 pt-yrs | Implantable Device | Warfarin Control |
|---|---|---|
| The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events | 3.5 (2.7 to 4.5) | 3.2 (2.1 to 4.4) |
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
| percentage of implant attempts | WATCHMAN |
|---|---|
| Procedure Success | 90.9 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roll-in | — | 29/93 (31.2%) | 19/93 (20.4%) |
| WATCHMAN | — | 143/463 (30.9%) | 71/463 (15.3%) |
| WARFARIN | — | 70/244 (28.7%) | 17/244 (7%) |
| Event | Roll-in | WATCHMAN | WARFARIN |
|---|---|---|---|
| DeathGeneral disorders | 5/93 | 59/463 | 44/244 |
| Gastrointestinal BleedingGastrointestinal disorders | 9/93 | 26/463 | 22/244 |
| Stroke - IschemicNervous system disorders | 5/93 | 24/463 | 10/244 |
| Other Study RelatedInvestigations | 4/93 | 17/463 | 2/244 |
| Pericardial Effusion with Cardiac TamponadeCardiac disorders | 4/93 | 13/463 | 0/244 |
| Stroke - HemorrhagicNervous system disorders | 0/93 | 3/463 | 10/244 |
| Bruising - HematomaVascular disorders | 2/93 | 5/463 | 0/244 |
| EpistaxisVascular disorders | 2/93 | 4/463 | 0/244 |
| Cardiac PerforationCardiac disorders | 1/93 | 7/463 | 0/244 |
| Transient Ischemic Attack (TIA)Nervous system disorders | 1/93 | 5/463 | 0/244 |
| Event | Roll-in | WATCHMAN | WARFARIN |
|---|---|---|---|
| Other Study RelatedInvestigations | 9/93 | 19/463 | 2/244 |
| EpistaxisVascular disorders | 4/93 | 11/463 | 5/244 |
| Pericardial EffusionCardiac disorders | 3/93 | 10/463 | 0/244 |
| Device ThrombusInvestigations | 2/93 | 14/463 | 0/244 |
| Rectal BleedingGastrointestinal disorders | 1/93 | 3/463 | 5/244 |
| Gastrointestinal BleedingGastrointestinal disorders | 1/93 | 3/463 | 2/244 |
| Transient Ischemic Attack (TIA)Nervous system disorders | 1/93 | 2/463 | 0/244 |
| Bruising - HematomaVascular disorders | 0/93 | 3/463 | 2/244 |
| HematuriaRenal and urinary disorders | 0/93 | 2/463 | 2/244 |
| Anemia Requiring TransfusionBlood and lymphatic system disorders | 0/93 | 2/463 | 1/244 |
2:1 randomazation, outcome analysis excludes the 93 subjects in the Roll-in arm
| Age, Continuous(years) | WATCHMAN | Warfarin Control | Roll-in | Total |
|---|---|---|---|---|
| Mean | 71.7 ± 8.8 | 72.7 ± 9.2 | 72.2 ± 8.9 | 72.0 ± 8.9 |
| Sex: Female, Male(Participants) | WATCHMAN | Warfarin Control | Roll-in | Total |
|---|---|---|---|---|
| Female | 137 | 73 | 28 | 238 |
| Male | 326 | 171 | 65 | 562 |
| Race/Ethnicity, Customized(participants) | WATCHMAN | Warfarin Control | Roll-in | Total |
|---|---|---|---|---|
| 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(participants) | WATCHMAN | Warfarin Control | Roll-in | Total |
|---|---|---|---|---|
| United States | 382 | 201 | 87 | 670 |
| Czech Republic | 19 | 10 | 3 | 32 |
| Germany | 62 | 33 | 3 | 98 |
The record gives a start of Feb 2005, a primary completion of Aug 2013 and a completion of May 2014. It does not say whether these dates are actual or estimated.
Results were first posted in May 2015, 1 year 9 months after primary completion.
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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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