Non-valvular Atrial Fibrillation (AF)
Conditions
Brief summary
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.
Detailed description
WATCHMAN FLX™ Pro CT is a prospective, single-arm, single-center, premarket investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX Pro device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used. A core laboratory will independently assess select results. A subject is considered enrolled in the study when the subject or the subject's legally authorized representative signs an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC). Up to 50 subjects in whom placement of a WATCHMAN FLX Pro device is attempted will be enrolled. A baseline assessment including TEE and/or CT imaging with optional cardiac magnetic resonance imaging (MRI) will be done within 7 days prior to the index procedure following core laboratory guidelines. Follow-up clinical assessment and imaging will occur at 14 days, 45 days, and 3 months post index procedure; only clinical assessment will be required at 12 months (unless an in-person assessment is required based on other data). Subjects who are enrolled but not implanted with a WATCHMAN FLX Pro LAAC device will be followed for safety through 12 months after the initial attempted index procedure but will not undergo imaging assessments or evaluation of biochemical markers including measures of coagulation, platelet and endothelial activation and inflammation.
Interventions
DEVICELeft atrial appendage closure device WM FLX Pro
Left atrial appendage closure
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 90 Years
Healthy volunteers
No
Inclusion criteria
* Subject is of legal age to participate in the study per the laws of their respective geography. * 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 a WATCHMAN FLX Pro device. * Subject is deemed suitable for the protocol-defined pharmacologic regimen. * 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device | 14 days to 3 months post implant | Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Arm Watchman FLX Pro Device Implantation | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | Device Arm | — |
|---|---|---|
| Age, Continuous | 74.6 years STANDARD_DEVIATION 7.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 43 Participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 43 |
| other Total, other adverse events | 9 / 43 |
| serious Total, serious adverse events | 23 / 43 |
Outcome results
Primary
Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device
Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging
Time frame: 14 days to 3 months post implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 14 Days | Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device | 3 Participants |
| 45 Days | Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device | 5 Participants |
| 3 Months | Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device | 5 Participants |