Clinical trial NCT03917563: Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
Official title: Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Keywords: atrial fibrillation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Hospital
name: the PLA General Hospital
name: Beijing Chao Yang Hospital
name: Peking University First Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai 10th People's Hospital
name: Changhai Hospital
name: Dongfang Hospital Affiliated to Tongji University
name: Shanghai 6th People's Hospital
name: Ruijin Hospital
name: Shanghai Thoracic Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: Tianjin Medical University General Hospital
name: Southwest Hospital, China
name: Shengjing Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Central Hospital of Dalian
name: General Hospital of Shenyang Military Region
name: Qilu Hospital of Shandong University
name: The Second Hospital of Hebei Medical University
name: Shanxi Cardiovascular Hospital
name: People's Hospital of Taizhou
name: The First Affiliated Hospital with Nanjing Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Ningbo No. 1 Hospital
name: Sir Run Shaw Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Wuhan Union Hospital, China
name: Wuhan Asia Heart Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: General Hospital of Ningxia Medical University
name: Sichuan Provincial People's Hospital
name: West China Hospital
name: ZhuHai Hospital
name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2019-04-17
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Bleeding
timeFrame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
measure: Vascular access-related complications
timeFrame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
measure: Device-related complications
timeFrame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao
role: PRINCIPAL_INVESTIGATOR
References: