Atrial Fibrillation, Bleeding, Stroke
Conditions
Brief summary
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
Interventions
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is of legal age to participate in the study. * Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). * Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. * Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. * Subject is able and willing to return for required follow-up visits and examinations.
Exclusion criteria
* Subject has a documented life expectancy of less than 6 months. * Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. * Intracardiac thrombus is present. * An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. * The LAA anatomy will not accommodate a Closure Device. * The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated. * Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. * There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. * Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects | 45 days | Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab). |
| Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects | 6 months | Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Analysis Subset Initial 500 enrolled subjects | 500 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Missed Visit | 2 |
| Overall Study | Other | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Primary Analysis Subset |
|---|---|
| Age, Customized <75 years | 188 Participants |
| Age, Customized ≥ 75 years | 312 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 471 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 441 Participants |
| Region of Enrollment United States | 500 participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 500 |
| other Total, other adverse events | 70 / 500 |
| serious Total, serious adverse events | 141 / 500 |
Outcome results
Primary
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Time frame: 45 days
Population: Implanted primary analysis subjects with 45-day TEE imaging.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Analysis Subset | Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects | 0 Participants |
Primary
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Analysis Subset | Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects | 54 Participants |