AMPLATZER™ Cardiac Plug Observational Post-Approval Study (ACP China)

The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single arm, post approval, observational study. The clinical study will be conducted at up to 35 sites in China. Approximately 343 subjects will be enrolled in this study.

The total study duration is expected to be approximately 7 years. The study population included patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin.

Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Intervention / Treatment: Device: AMPLATZER™ Cardiac Plug

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • The First Affiliated Hospital of Sun Yat-Sen University
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310016
      • Sir Run Run Shaw Hospital
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan Asia Heart Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Liuting Saint
    • Ningbo, Liuting Saint, China, 315000
      • Ningbo First Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or relevant event despite taking warfarin.

Description

Inclusion Criteria:

1. Patient who meets the current indications and per physician discretion for ACP implant
2. Patient who is ≥ 18 years of age at the time of enrolment
3. Patient who is able to provide written Informed Consent prior to any study related procedures

Exclusion Criteria:

1. Patient who is unable to comply with the follow-up schedule
2. Patient with the presence of intracardiac thrombus
3. Patient with active endocarditis or other infections producing bacteraemia
4. Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score<3)
5. Patient where placement of the device would interfere with any intracardiac or intravascular structures
6. Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator
7. Patient with LAA anatomy that does not accommodate a device per the sizing guidelines
8. Patient who has a life expectancy of less than 2 years due to any condition
9. Patient who are currently participating in a clinical investigation that includes an active treatment arm
10. Patient who already had a left atrial appendage closure device implanted prior to the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

AMPLATZER™ Cardiac Plug; Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.

Device: AMPLATZER™ Cardiac Plug; The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention	The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.	Within 7 days of the procedure
Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy	The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.	Within 2 years of the procedure
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism	The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.	Within 2 years of the procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2016
• Primary Completion (ACTUAL): January 29, 2021
• Study Completion (ACTUAL): January 29, 2021

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (ESTIMATE): November 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Warfarin; Anticoagulant; Non-valvular atrial fibrillation (NVAF)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SJM-CIP-CRD 881; SJM-CIP-10153 (OTHER: Abbott Medical (Note:protocol ID shown in Abbott system))