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Terminated

NCT Number: NCT06189365

Amplatzer Amulet China Post Market Study (PMS)

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.

Why the study stopped: This study was terminated due to the shift in Sponsor's business strategy.
Terminated

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Meets the current device indications and per physician discretion for Amulet implant
  • Able to provide written Informed Consent prior to any study related procedures
  • 18 years of age or older at the time of enrolment

Exclusion criteria

  • With the presence of intracardiac thrombus
  • With active endocarditis or other infections producing bacteremia
  • Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score < 3)
  • Where placement of the device would interfere with any intracardiac or intravascular structures
  • Has a life expectancy of less than 2 years due to any condition
  • 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

Treatment and study plan

Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder

Device

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

Primary outcomes

  1. Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events

    Time frame: 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.

  2. Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy

    Time frame: 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.

    The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.

  3. Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism

    Time frame: 2 years

    The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years.

    The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.

Other outcomes

  1. Descriptive Endpoint: Composite of Damage to Blood Vessel or Organ or Damage to Adjacent Organs at Implant, Device Dislodgement, Device Fracture, Device Erosion, or Pericardial Tamponade

    Time frame: 5 years

    Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure.

    The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.

  2. Descriptive Endpoint: Rate of Device Success

    Time frame: During implant procedure, approximately 30 to 60 minutes

    Rate of device success - defined as device deployed and implanted in correct position

  3. Descriptive Endpoint: Rate of Device Closure

    Time frame: 3 months

    Rate of device closure - defined as residual jet around the device of ≤ 5mm, based on the 3-month transesophageal echocardiogram (TEE) defined by Doppler flow

  4. Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs

    Time frame: 5 years

    Descriptive Endpoint: Percentage of subjects taking OAC or antiplatelet drugs through 5 years.

    The protocol-defined time frame for endpoint assessment was 5 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2024
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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