NCT03917563

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 14, 2019

Last Update Submit

April 14, 2019

Conditions

Non-valvular Atrial Fibrillation

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death

    12 months post procedure

Secondary Outcomes (3)

  • Bleeding

    Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure

  • Vascular access-related complications

    Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure

  • Device-related complications

    Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure

Study Arms (1)

Intervention group

EXPERIMENTAL

WATCHMAN LAA occluder treatment

Device: WATCHMAN LAA occluder

Interventions

WATCHMAN LAA occluderDEVICE

WATCHMAN LAA occluder

Intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Tao

Xi’an, Shanxi, 710054, China

Location

Related Publications (1)

  • 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.

    PMID: 39553900DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ling Tao

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

86-29-84775183lingtao@fmmu.edu.cn

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

CONTACT

86-29-84775183liuyimeishan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 17, 2019

Study Start

April 20, 2019

Primary Completion

April 20, 2021

Study Completion

April 20, 2024

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

CN(1)