NCT02954237

AMPLATZER™ Cardiac Plug Observational Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-valvular Atrial Fibrillation (NVAF)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-11-14
• Primary completion: 2021-01-29
• Completion: 2021-01-29
• First posted: 2016-11-03
• Last updated: 2022-06-24
• Results posted: 2022-06-24

Locations

6 sites across 1 country: China