Amplatzer Amulet China Post Market Study (PMS)

Active, not recruiting

• Conditions: Non-Valvular Atrial Fibrillation
• Interventions: Device: Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder

• Registration Number: NCT06189365
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-03
• Study Start: 2024-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2027-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
2. Meets the current device indications and per physician discretion for Amulet implant
3. Able to provide written Informed Consent prior to any study related procedures
4. 18 years of age or older at the time of enrolment

Exclusion Criteria

1. With the presence of intracardiac thrombus
2. With active endocarditis or other infections producing bacteremia
3. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score < 3)
4. Where placement of the device would interfere with any intracardiac or intravascular structures
5. Has a life expectancy of less than 2 years due to any condition
6. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amplatzer Amulet LAA occluder	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.

Primary Outcome Measures

Name	Time	Method
Composite of ischemic stroke or systemic embolism	2 years	The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years.
Occurrence of device embolization,device erosion,clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections(endocarditis and pericarditis), device breakage, or device related allergy	2 years	The primary long-term safety endpoint is the occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections (endocarditis and pericarditis), device breakage, or device related allergy through 2 years.
Occurrence of major adverse events	7 days	The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism.

Trial Locations

Locations (5)

University of Hong Kong-Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Xianyang Hospital Of Yan'an University; 🇨🇳 Xianyang, Shaanxi, China

Xiangya Hospital Zhuzhou Central South University; 🇨🇳 Zhuzhou, Hunan, China