Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology

Not Applicable

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT03917563
• Lead Sponsor: Xijing Hospital

Brief Summary

The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-14
• Last Update Submitted: 2019-04-14
• Study First Posted: 2019-04-17
• Last Update Posted: 2019-04-17
• Study Start: 2019-04-20
• Primary Completion: 2021-04-20
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Patient is 18 years of age or above;
2. Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
3. Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.

Exclusion Criteria

1. Patient is 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.
2. Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
3. Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death	12 months post procedure

Secondary Outcome Measures

Name	Time	Method
Bleeding	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure	Life threatening or disabling, major bleeding and Minor bleeding
Vascular access-related complications	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure	Haematoma at access site\<6 cm; Retroperitoneal haematoma;Arteriovenous fistula;Vascular surgical repair at catheter access sites;Pulmonary embolism;Ipsilateral deep vein thrombosis;Access site-related infection requiring intravenous antibiotics or extended hospitalization
Device-related complications	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure	Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shanxi, China