Back to resultsRegistry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology (RECORD)
Primary Purpose
Non-valvular Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WATCHMAN LAA occluder
Sponsored by
About this trial
This is an interventional treatment trial for Non-valvular Atrial Fibrillation focused on measuring atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 years of age or above;
- Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
- 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:
- 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.
- 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.
- Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
Sites / Locations
- Ling Tao
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
WATCHMAN LAA occluder treatment
Outcomes
Primary Outcome Measures
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Secondary Outcome Measures
Bleeding
Life threatening or disabling, major bleeding and Minor bleeding
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
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
Full Information
NCT ID
NCT03917563
First Posted
April 14, 2019
Last Updated
April 14, 2019
Sponsor
Xijing Hospital
Collaborators
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, Wuhan Union Hospital, China, 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
1. Study Identification
Unique Protocol Identification Number
NCT03917563
Brief Title
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
Acronym
RECORD
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 20, 2019 (Anticipated)
Primary Completion Date
April 20, 2021 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
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, Wuhan Union Hospital, China, 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation
Keywords
atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1050 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
WATCHMAN LAA occluder treatment
Intervention Type
Device
Intervention Name(s)
WATCHMAN LAA occluder
Intervention Description
WATCHMAN LAA occluder
Primary Outcome Measure Information:
Title
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Bleeding
Description
Life threatening or disabling, major bleeding and Minor bleeding
Time Frame
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Title
Vascular access-related complications
Description
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
Time Frame
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Title
Device-related complications
Description
Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy
Time Frame
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 years of age or above;
Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
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:
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.
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.
Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Tao, Ph.D.,M.D.
Phone
86-29-84775183
Email
lingtao@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Liu, Ph.D.,M.D.
Phone
86-29-84775183
Email
liuyimeishan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Tao
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ling Tao
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Tao, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
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