Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Conditions
Keywords
Atrial fibrillation, Stroke, Thrombus, Thromboembolism, Left atrial appendage
Brief summary
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
Detailed description
Approximately 1000 subjects will be enrolled in the study. To reduce the impact of individual center bias, each site may include up to 45 subjects and each country may include a maximum of 500 patients. Up to 70 sites (international, outside of US) will participate in the study. Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study. Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at one post-implant visit (typically between 1-3 months of implant), and then annually through 2 years post implant. An intermediate visit may be scheduled in a number of patients, per physician discretion. In order to reliably capture patient status at study end, a follow-up window of 24 +/- 3 months will be considered acceptable for scheduling the last visit. For subjects who are not scheduled to visit the clinic for a follow-up, a subject contact (e.g. phone call) will ensure capture of the endpoint related information; however, it is recommended to perform an in-office visit for at least the first annual visit. Enrollment is expected to be completed in 21 months; therefore, the total study duration is estimated to be 48 months.
Interventions
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion; * Patient who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center; * Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion criteria
* Patient who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); * The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Complications | 7 days post-implant | All device/procedure related Serious Adverse Events (with or without Major intervention) |
| Ischemic Stroke | 2 year follow-up | occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU |
| Death | 2 year follow-up | All cause mortality |
Countries
Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Spain, United Arab Emirates, United Kingdom
Participant flow
Recruitment details
1025 patients scheduled for a WATCHMAN implant at 47 centers in 13 countries were enrolled over a time period of 19 months prior to the start of the procedure (Oct 2013 - May 2015)
Pre-assignment details
5 patients signed the informed consent but never underwent the implant procedures. Those patients are classified as intents, they are included in epidemiological baseline analyses, but not on the endpoint analysis. 1020 patients underwent the implant procedure and are included in all endpoint analyses, regardless of the success of the implant.
Participants by arm
| Arm | Count |
|---|---|
| WATCHMAN Patients who are implanted with the WATCHMAN device in a commercial clinical setting. | 1,025 |
| Total | 1,025 |
Baseline characteristics
| Characteristic | WATCHMAN | — |
|---|---|---|
| Age, Continuous | 73.4 years STANDARD_DEVIATION 8.9 | — |
| CHADS-VASc | 4.5 scores on a scale STANDARD_DEVIATION 1.6 | — |
| HAS-BLED | 2.3 scores on a scale STANDARD_DEVIATION 1.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 23 Participants | — |
| Region of Enrollment France | 61 Participants | — |
| Region of Enrollment Germany | 532 Participants | — |
| Region of Enrollment Ireland | 37 Participants | — |
| Region of Enrollment Italy | 56 Participants | — |
| Region of Enrollment Netherlands | 79 Participants | — |
| Region of Enrollment Poland | 38 Participants | — |
| Region of Enrollment Portugal | 17 Participants | — |
| Region of Enrollment Russian Federation | 81 Participants | — |
| Region of Enrollment Saudi Arabia | 15 Participants | — |
| Region of Enrollment Spain | 20 Participants | — |
| Region of Enrollment United Arab Emirates | 8 Participants | — |
| Region of Enrollment United Kingdom | 58 Participants | — |
| Sex: Female, Male Female | 411 Participants | — |
| Sex: Female, Male Male | 614 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 161 / 1,020 |
| other Total, other adverse events | 0 / 1,020 |
| serious Total, serious adverse events | 26 / 1,020 |
Outcome results
Primary
Death
All cause mortality
Time frame: 2 year follow-up
Population: Patients who undergo WATCHMAN implant in a commercial clinical setting.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WATCHMAN | Death | 161 Participants |
Primary
Ischemic Stroke
occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU
Time frame: 2 year follow-up
Population: Patients who undergo WATCHMAN implant procedure in a commercial clinical setting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WATCHMAN | Ischemic Stroke | 1.26 Nr events/100 Patient-years |
Primary
Procedural Complications
All device/procedure related Serious Adverse Events (with or without Major intervention)
Time frame: 7 days post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WATCHMAN | Procedural Complications | 2.8 percentage of participants |