- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917563
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology (RECORD)
April 14, 2019 updated by: Xijing Hospital
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1050
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ling Tao, Ph.D.,M.D.
- Phone Number: 86-29-84775183
- Email: lingtao@fmmu.edu.cn
Study Contact Backup
- Name: Yi Liu, Ph.D.,M.D.
- Phone Number: 86-29-84775183
- Email: liuyimeishan@hotmail.com
Study Locations
-
-
Shanxi
-
Xi'an, Shanxi, China, 710054
- Ling Tao
-
Contact:
- Ling Tao, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
WATCHMAN LAA occluder treatment
|
WATCHMAN LAA occluder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death
Time Frame: 12 months post procedure
|
12 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding
Time Frame: Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
|
Life threatening or disabling, major bleeding and Minor bleeding
|
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
|
Vascular access-related complications
Time Frame: 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
|
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
|
Device-related complications
Time Frame: 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
|
Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 20, 2019
Primary Completion (Anticipated)
April 20, 2021
Study Completion (Anticipated)
April 20, 2024
Study Registration Dates
First Submitted
April 14, 2019
First Submitted That Met QC Criteria
April 14, 2019
First Posted (Actual)
April 17, 2019
Study Record Updates
Last Update Posted (Actual)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 14, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20182078-X-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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