AMPLATZER™ Cardiac Plug Observational Post-Approval Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AMPLATZER™ Cardiac Plug

Device

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)

Primary outcomes

Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention

Time frame: Within 7 days of the procedure

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.
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

Time frame: Within 2 years of the procedure

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.
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism

Time frame: Within 2 years of the procedure

The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: ACP China

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Nov 3, 2016
Registry last updated: Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed