Atrial Fibrillation
Conditions
Brief summary
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.
Interventions
DEVICEWATCHMAN FLX
Left atrial appendage closure with WATCHMAN FLX
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is 18 years of age or older. 2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease). 3. The subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN FLX Device implant. 4. The subject is eligible to come off of anticoagulation therapy if the LAA is sealed (i.e., the subject has no other conditions that would require long-term anticoagulation therapy suggested by current standard medical practice). 5. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females. 6. The subject is able to understand and willing to provide written informed consent to participate in the trial. 7. The subject is able and willing to return for required follow-up visits and examinations.
Exclusion criteria
1. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed. 2. The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoaguable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue anticoagulation due to other medical conditions requiring chronic anticoagulation therapy). 3. The subject is contraindicated for short-term anticoagulant therapy with DOAC post-implant. 4. The subject is contraindicated to aspirin and/or clopidogrel. 5. The subject is indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to the WATCHMAN FLX Device implant. 6. The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN FLX Device implant (including, but not limited to: cardioversion, coronary angiogram with or without percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, endoscopy, etc.). 7. The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment. 8. The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment. 9. The subject has a history of atrial septal repair or has an ASD/PFO device. 10. The subject has an implanted mechanical valve prosthesis in any position. 11. The subject currently has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment. 12. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion). 13. The subject has a documented life expectancy of less than 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Safety Event | events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later | The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint. |
| Number of Participants With Effective LAA Closure | 12-months | The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WATCHMAN FLX - M Main Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | 400 |
| WATCHMAN FLX - R Roll-In Cohort
WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | 58 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 36 | 7 |
| Overall Study | Lost to Follow-up | 12 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Unsuccessful Implant Attempt | 5 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | WATCHMAN FLX - M | WATCHMAN FLX - R | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 345 Participants | 51 Participants | 396 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 7 Participants | 62 Participants |
| Age, Continuous | 73.8 years STANDARD_DEVIATION 8.6 | 75.2 years STANDARD_DEVIATION 8.5 | 74.0 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 0 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 390 Participants | 58 Participants | 448 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 2 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 5 Participants | 26 Participants |
| Race (NIH/OMB) White | 358 Participants | 51 Participants | 409 Participants |
| Region of Enrollment United States | 400 participants | 58 participants | 458 participants |
| Sex: Female, Male Female | 142 Participants | 24 Participants | 166 Participants |
| Sex: Female, Male Male | 258 Participants | 34 Participants | 292 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 36 / 400 | 7 / 58 |
| other Total, other adverse events | 96 / 400 | 15 / 58 |
| serious Total, serious adverse events | 157 / 400 | 25 / 58 |
Outcome results
Primary
Number of Participants With a Safety Event
The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.
Time frame: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WATCHMAN FLX - M | Number of Participants With a Safety Event | 2 Participants |
| WATCHMAN FLX - R | Number of Participants With a Safety Event | 0 Participants |
Primary
Number of Participants With Effective LAA Closure
The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.
Time frame: 12-months
Population: The Primary Effectiveness Endpoint is the rate of effective LAA closure at 12 months (defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE). The overall number of participants analyzed (342 in main and 52 in roll-in cohort) are the number of participants who had evaluable 12 month core lab f/u data from the total number of participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WATCHMAN FLX - M | Number of Participants With Effective LAA Closure | 342 Participants |
| WATCHMAN FLX - R | Number of Participants With Effective LAA Closure | 52 Participants |