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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917563
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
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
Information provided by (Responsible Party):
Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Non-valvular Atrial Fibrillation Device: WATCHMAN LAA occluder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : April 20, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
WATCHMAN LAA occluder treatment
Device: WATCHMAN LAA occluder
WATCHMAN LAA occluder




Primary Outcome Measures :
  1. The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death [ Time Frame: 12 months post procedure ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917563


Contacts
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Contact: Ling Tao, Ph.D.,M.D. 86-29-84775183 lingtao@fmmu.edu.cn
Contact: Yi Liu, Ph.D.,M.D. 86-29-84775183 liuyimeishan@hotmail.com

Locations
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China, Shanxi
Ling Tao
Xi'an, Shanxi, China, 710054
Contact: Ling Tao, MD, PhD         
Sponsors and Collaborators
Xijing Hospital
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
Investigators
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Principal Investigator: Ling Tao Xijing Hospital
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03917563    
Other Study ID Numbers: KY20182078-X-1
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes