China REgistry of WATCHMAN (CREW)
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|ClinicalTrials.gov Identifier: NCT03014557|
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Left Atrial Appendage Closure||Device: left atrial appendage closure device implantation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||413 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device
Device: left atrial appendage closure device implantation
to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach
- all-cause death, ischemic stroke, systemic embolism, or device or procedure related events [ Time Frame: 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. [ Time Frame: 2 years ]
- Implantation success rate. [ Time Frame: 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 [ Time Frame: excluding the first 7 days post enrollment. ]
- All Major Complications. [ Time Frame: 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. [ Time Frame: up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014557
|Contact: Zhengqin Zhai, MD PhDemail@example.com|
|Contact: Zhengqin Zhai, MD PhD firstname.lastname@example.org|