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

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129545
Enrollment
800
Registered
2005-08-12
Start date
2005-02-28
Completion date
2014-05-31
Last updated
2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Blood thinning medication, transient ischemic attack (TIA), WATCHMAN, Left atrial appendage, LAA isolation, LAA occlusion

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWATCHMAN Left Atrial Appendage Closure Technology

Implant of WATCHMAN Left Atrial Appendage Closure Technology

DRUGWarfarin

Subjects receive warfarin

Sponsors

Boston Scientific Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF) * Eligible for long term warfarin * CHADS score \>= 1 \[congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)\]

Exclusion criteria

* Contraindicated for warfarin * Contraindicated for aspirin or clopidogrel (Plavix) * Congestive heart failure (CHF) Class 4 * Implanted mechanical valve * Atrial septal or Patent Foramen Ovale (PFO) device * Platelets \< 100,000 or hemoglobin \< 10 * Left ventricular ejection fraction (LVEF) \< 30%

Design outcomes

Primary

MeasureTime frameDescription
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death5 yearsA 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)
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events5 yearsSerious 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.

Secondary

MeasureTime frameDescription
Procedure SuccessInitial implant procedureImplant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Countries

Czechia, Germany, United States

Participant flow

Participants by arm

ArmCount
WATCHMAN
WATCHMAN Left Atrial Appendage Closure Technology:
463
Warfarin Control
Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
244
Roll-in
Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
93
Total800

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath56044
Overall StudyDevice not implanted16610
Overall StudyLost to Follow-up22213
Overall StudyPhysician Decision0310
Overall StudyWithdrawal by Subject31844

Baseline characteristics

CharacteristicTotalRoll-inWarfarin ControlWATCHMAN
Age, Continuous72.0 years
STANDARD_DEVIATION 8.9
72.2 years
STANDARD_DEVIATION 8.9
72.7 years
STANDARD_DEVIATION 9.2
71.7 years
STANDARD_DEVIATION 8.8
Race/Ethnicity, Customized
Asian
5 participants0 participants1 participants4 participants
Race/Ethnicity, Customized
Black/African American
14 participants3 participants5 participants6 participants
Race/Ethnicity, Customized
Caucasian
734 participants87 participants222 participants425 participants
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
2 participants0 participants1 participants1 participants
Race/Ethnicity, Customized
Hispanic/Latino
43 participants3 participants15 participants25 participants
Race/Ethnicity, Customized
other
2 participants0 participants0 participants2 participants
Region of Enrollment
Czech Republic
32 participants3 participants10 participants19 participants
Region of Enrollment
Germany
98 participants3 participants33 participants62 participants
Region of Enrollment
United States
670 participants87 participants201 participants382 participants
Sex: Female, Male
Female
238 Participants28 Participants73 Participants137 Participants
Sex: Female, Male
Male
562 Participants65 Participants171 Participants326 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
19 / 9371 / 46317 / 244
serious
Total, serious adverse events
29 / 93143 / 46370 / 244

Outcome results

Primary

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

Population: 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.

ArmMeasureValue (NUMBER)
Implantable DeviceComposite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death2.2 events per 100 pt yrs
Warfarin ControlComposite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death3.7 events per 100 pt yrs
95% CI: [0.42, 1.07]
Primary

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

Population: 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.

ArmMeasureValue (NUMBER)
Implantable DeviceThe Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events3.5 Events per 100 pt-yrs
Warfarin ControlThe Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events3.2 Events per 100 pt-yrs
Secondary

Procedure Success

Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Time frame: Initial implant procedure

Population: 14 subjects did not have an implant procedure attempted

ArmMeasureValue (NUMBER)
Implantable DeviceProcedure Success90.9 percentage of implant attempts

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026