Clinical trial NCT06189365: Amplatzer Amulet China Post Market Study (PMS)
Official title: Amplatzer Amulet China Post Market Study (PMS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Valvular Atrial Fibrillation
Keywords: Non-Valvular Atrial Fibrillation
NVAF
Amplatzer Amulet
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll subjects of all genders from the Chinese nationality general population ≥18 years old. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of major adverse events
timeFrame: 7 days
measure: 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
timeFrame: 2 years
measure: Composite of ischemic stroke or systemic embolism
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Rate of ischemic stroke or systemic embolism
timeFrame: 5 years
measure: Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade
timeFrame: 5 years
measure: Rate of device success
timeFrame: During implant procedure, approximately 30 to 60 minutes
measure: Rate of device closure
timeFrame: 3 months
measure: Percentage of subjects taking OAC or antiplatelet drugs
timeFrame: 5 years
Locations:
city: Shenzhen
country: China
facility: University of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Zhuzhou
country: China
facility: Xiangya Hospital Zhuzhou Central South University
state: Hunan
city: Xianyang
country: China
facility: Xianyang Hospital Of Yan'an University
state: Shaanxi
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Zhihui ZHANG
role: PRINCIPAL_INVESTIGATOR
References: