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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Non-valvular Atrial Fibrillation
• Intervention / Treatment: Device: WATCHMAN LAA occluder

• Study Type: Interventional
• Enrollment (Anticipated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ling Tao, Ph.D.,M.D.; Phone Number: 86-29-84775183; Email: lingtao@fmmu.edu.cn
• Study Contact Backup: Name: Yi Liu, Ph.D.,M.D.; Phone Number: 86-29-84775183; Email: liuyimeishan@hotmail.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710054
      • Ling Tao
      • Contact: Ling Tao, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; WATCHMAN LAA occluder treatment	Device: WATCHMAN LAA occluder; WATCHMAN LAA occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite primary endpoint of the stroke, systemic embolism, or cardiovascular or unexplained death	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Life threatening or disabling, major bleeding and Minor bleeding	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Vascular access-related complications	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	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure
Device-related complications	Device embolization; Device erosion;Clinically significant device interference with surrounding structure;Device thrombus;Device fracture;Device infection/endocarditis/pericarditis;Device perforation/laceration;Device allergy	Periprocedure and 1,5,6, 12, 24, 36, 48, 60 month post procedure

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital; General Hospital of Shenyang Military Region; Changhai Hospital; Beijing Tiantan Hospital; The Second Hospital of Hebei Medical University; Southwest Hospital, China; West China Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shengjing Hospital; First Affiliated Hospital Xi'an Jiaotong University; Shanghai 10th People's Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Ruijin Hospital; Beijing Chao Yang Hospital; Beijing Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Wuhan Union Hospital, China; Tianjin Medical University General Hospital; Second Affiliated Hospital of Wenzhou Medical University; Wuhan Asia Heart Hospital; General Hospital of Ningxia Medical University; First Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital of Xinjiang Medical University; Ningbo No. 1 Hospital; Sichuan Provincial People's Hospital; The First Affiliated Hospital of Dalian Medical University; Shanghai 6th People's Hospital; Shanxi Cardiovascular Hospital; ZhuHai Hospital; Shenzhen Sun Yat-sen Cardiovascular Hospital; the PLA General Hospital; Dongfang Hospital Affiliated to Tongji University; Shanghai Thoracic Hospital; Central Hospital of Dalian; People's Hospital of Taizhou; Sir Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2019
• Primary Completion (Anticipated): April 20, 2021
• Study Completion (Anticipated): April 20, 2024

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 14, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 14, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KY20182078-X-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No