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

Non-valvular Atrial Fibrillation Clinical Trial

— RECORD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03917563
• Other study ID #: KY20182078-X-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2019
• Source: Xijing Hospital
• Contact: Ling Tao, Ph.D.,M.D.
• Phone: 86-29-84775183
• Email: lingtao[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1050
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Device:
• WATCHMAN LAA occluder
WATCHMAN LAA occluder

Locations

Country	Name	City	State
China	Ling Tao	Xi'an	Shanxi

Sponsors (40)

Lead Sponsor

Collaborator

Xijing Hospital

Beijing Chao Yang Hospital, Beijing Hospital, Beijing Tiantan Hospital, Central Hospital of Dalian, Changhai Hospital, Dongfang Hospital Affiliated to Tongji University, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, General Hospital of Ningxia Medical University, General Hospital of Shenyang Military Region, Ningbo No. 1 Hospital, Peking University First Hospital, People's Hospital of Taizhou, Qilu Hospital of Shandong University, Ruijin Hospital, Second Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Thoracic Hospital, Shanxi cardiovascular hospital, Shengjing Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, Sichuan Provincial People's Hospital, Sir Run Shaw Hospital, Southwest Hospital, China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital with Nanjing Medical University, the PLA General Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, West China Hospital, Wuhan Asia Heart Hospital, Wuhan Union Hospital, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death		12 months post procedure
Secondary	Bleeding	Life threatening or disabling, major bleeding and Minor bleeding	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Secondary	Vascular access-related complications	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	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Secondary	Device-related complications	Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure