Non-valvular Atrial Fibrillation
Conditions
Keywords
atrial fibrillation
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
Interventions
DEVICEWATCHMAN LAA occluder
WATCHMAN LAA occluder
Sponsors
Beijing Tiantan Hospital
Beijing Hospital
the PLA General Hospital
Beijing Chao Yang Hospital
Peking University First Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai 10th People's Hospital
Changhai Hospital
Dongfang Hospital Affiliated to Tongji University
Shanghai 6th People's Hospital
Ruijin Hospital
Shanghai Thoracic Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shenzhen Sun Yat-sen Cardiovascular Hospital
Tianjin Medical University General Hospital
Southwest Hospital, China
Shengjing Hospital
The First Affiliated Hospital of Dalian Medical University
Central Hospital of Dalian
General Hospital of Shenyang Military Region
Qilu Hospital of Shandong University
The Second Hospital of Hebei Medical University
Shanxi Cardiovascular Hospital
People's Hospital of Taizhou
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Second Affiliated Hospital, School of Medicine, Zhejiang University
Ningbo No. 1 Hospital
Sir Run Shaw Hospital
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Asia Heart Hospital
First Affiliated Hospital Xi'an Jiaotong University
General Hospital of Ningxia Medical University
Sichuan Provincial People's Hospital
West China Hospital
ZhuHai Hospital
First Affiliated Hospital of Xinjiang Medical University
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death | 12 months post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLing Tao, Ph.D.,M.D.
Backup ContactYi Liu, Ph.D.,M.D.
Outcome results
None listed