NCT06189365

Amplatzer Amulet China Post Market Study (PMS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Detailed description

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA. Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC. The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020. The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Conditions

• Non-Valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder	Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder.

Timeline

• Start date: 2024-01-30
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2024-01-03
• Last updated: 2025-12-18

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated device study