China REgistry of WATCHMAN

NCT03014557 | Unknown DMC

• 1 other identifier: T2016-ZX021
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure

Keywords

atrial fibrillation; left atrial appendage closure; WATCHMAN

Outcome Measures

Primary Outcomes (2)

• all-cause death, ischemic stroke, systemic embolism, or device or procedure related events

  events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.

  between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later

• composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.

  2 years

Secondary Outcomes (4)

• Implantation success rate.

  procedure

• Ischemic stroke or systemic embolism

  excluding the first 7 days post enrollment.

• All Major Complications.

  up to 5 years

• All-cause death.

  up to 5 years

Study Arms (1)

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

Interventions

left atrial appendage closure device implantation DEVICE

to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach

WATCHMAN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non-valvular atrial fibrillation

You may qualify if:

• Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:
• not suitable for long-term anti-coagulation therapy;
• stroke or embolism events in spite of warfarin treatment with intended INR
• HAS-BLED≥3

You may not qualify if:

• Patient with any one of the following items will be excluded from the study:
• subject is not able to or will not complete the follow ups as planned

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhengqin Zhai, MD PhD

CONTACT

384358085@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Arrhythmia

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)