AMPLATZER™ Cardiac Plug Observational Post-Approval Study

Abbott Medical Devices91 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Interventions

AMPLATZER™ Cardiac PlugDEVICE

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Sir Run Run Shaw Hospital

Zhejiang, Hangzhou, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Ningbo First Hospital

Ningbo, Liuting Saint, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Within 2 years of the procedure