Atrial Fibrillation, Left Atrial Appendage Closure
Conditions
Keywords
atrial fibrillation, left atrial appendage closure, WATCHMAN
Brief summary
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
Detailed description
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
Interventions
DEVICEleft atrial appendage closure device implantation
to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach
Sponsors
Boston Scientific Corporation
Fu Wai Hospital, Beijing, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items: 1. not suitable for long-term anti-coagulation therapy; 2. stroke or embolism events in spite of warfarin treatment with intended INR 3. HAS-BLED≥3
Exclusion criteria
Patient with any one of the following items will be excluded from the study: 1\. clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause death, ischemic stroke, systemic embolism, or device or procedure related events | between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later | events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. |
| composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death. | 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation success rate. | procedure | Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary. |
| Ischemic stroke or systemic embolism | excluding the first 7 days post enrollment. | — |
| All Major Complications. | up to 5 years | Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure. |
| All-cause death. | up to 5 years | — |
Countries
China
Contacts
Primary ContactZhengqin Zhai, MD PhD
Outcome results
None listed