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China REgistry of WATCHMAN (CREW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Fu Wai Hospital, Beijing, China
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Shu Zhang, Fu Wai Hospital, Beijing, China
ClinicalTrials.gov Identifier:
NCT03014557
First received: January 4, 2017
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.

Condition Intervention
Atrial Fibrillation
Left Atrial Appendage Closure
Device: left atrial appendage closure device implantation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Fu Wai Hospital, Beijing, China:

Primary Outcome Measures:
  • all-cause death, ischemic stroke, systemic embolism, or device or procedure related events [ Time Frame: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later ]
    events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.

  • composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Implantation success rate. [ Time Frame: procedure ]
    Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.

  • Ischemic stroke or systemic embolism [ Time Frame: excluding the first 7 days post enrollment. ]
  • All Major Complications. [ Time Frame: up to 5 years ]
    Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure.

  • All-cause death. [ Time Frame: up to 5 years ]

Estimated Enrollment: 413
Study Start Date: November 2016
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
WATCHMAN
subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device
Device: left atrial appendage closure device implantation
to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

Detailed Description:
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non-valvular atrial fibrillation
Criteria

Inclusion Criteria:

Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:

  1. not suitable for long-term anti-coagulation therapy;
  2. stroke or embolism events in spite of warfarin treatment with intended INR
  3. HAS-BLED≥3

Exclusion Criteria:

Patient with any one of the following items will be excluded from the study:

1. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life < 5 years

2 Echocardiography exclusion criteria (any of the items) a LVEF<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter >32mm or < 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area <1.5cm2)

3 subject is not able to or will not complete the follow ups as planned

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03014557

Contacts
Contact: Zhengqin Zhai, MD PhD 384358085@qq.com

Locations
China
Fuwai Hospital Recruiting
Beijing, China
Contact: Zhengqin Zhai, MD PhD       384358085@qq.com   
Sponsors and Collaborators
Fu Wai Hospital, Beijing, China
Boston Scientific Corporation
  More Information

Responsible Party: Shu Zhang, Director of Department of Arrhythmia, Fu Wai Hospital, Beijing, China
ClinicalTrials.gov Identifier: NCT03014557     History of Changes
Other Study ID Numbers: T2016-ZX021 
Study First Received: January 4, 2017
Last Updated: January 5, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Fu Wai Hospital, Beijing, China:
atrial fibrillation
left atrial appendage closure
WATCHMAN

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 24, 2017