AMPLATZER™ Cardiac Plug Observational Post-Approval Study (ACP PAS China) (ACP PAS China)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02954237|
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2016
Last Update Posted : July 7, 2020
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. 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+ 2 weeks), 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.
|Condition or disease||Intervention/treatment|
|Non-valvular Atrial Fibrillation (NVAF)||Device: AMPLATZER™ Cardiac Plug|
|Study Type :||Observational|
|Estimated Enrollment :||343 participants|
|Official Title:||AMPLATZER™ Cardiac Plug Observational Post-Approval Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- 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)
- Major adverse events: Short term occurrence of death, stroke (ischemic or haemorrhagic), systemic embolism, or procedure or device-related complications requiring major cardiovascular or endovascular intervention. [ Time Frame: within 7 days after the procedure ]
- Long term occurrence of device related complication [ Time Frame: The next 2 years after the procedure ]The 2-year occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis / pericarditis), device perforation, device laceration, or device allergy.(Refer to Protect AF Study)
- Effectiveness [ Time Frame: The next 2 years after the procedure ]The 2-year rate of the composite of ischemic stroke or systemic embolism