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

NCT ID: NCT03917563

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2024-04-20

Brief Summary

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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

Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

WATCHMAN LAA occluder treatment

Group Type EXPERIMENTAL

WATCHMAN LAA occluder

Intervention Type DEVICE

WATCHMAN LAA occluder

Interventions

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WATCHMAN LAA occluder

WATCHMAN LAA occluder

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

the PLA General Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Dongfang Hospital Affiliated to Tongji University

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai Thoracic Hospital

UNKNOWN

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shenzhen Sun Yat-sen Cardiovascular Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Central Hospital of Dalian

UNKNOWN

Sponsor Role collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Shanxi Cardiovascular Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Taizhou

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

Sir Run Shaw Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

ZhuHai Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ling Tao

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Ling Tao

Xi’an, Shanxi, China

Site Status

Countries

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China

Central Contacts

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Ling Tao, Ph.D.,M.D.

Role: CONTACT

86-29-84775183

Yi Liu, Ph.D.,M.D.

Role: CONTACT

86-29-84775183

Facility Contacts

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Ling Tao, MD, PhD

Role: primary

References

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Gao C, Su F, Liu J, Zhang T, Ning Z, Yang B, Chu H, He B, Zhang J, Zhou L, Li Y, Zhang Y, Hu H, Xu Y, Zeng J, Guo J, Su X, Ruan ZB, Liu H, Wang P, Garg S, Soliman O, Holmes DR Jr, Serruys PW, Tao L; RECORD Investigators. 1-Year Clinical Outcomes and the Impact of Procedural Configurations in Left Atrial Appendage Occlusion Patients. JACC Asia. 2024 Oct 1;4(10):777-790. doi: 10.1016/j.jacasi.2024.07.013. eCollection 2024 Oct.

Reference Type DERIVED
PMID: 39553900 (View on PubMed)

Other Identifiers

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KY20182078-X-1

Identifier Type: -

Identifier Source: org_study_id

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