Amplatzer Amulet China Post Market Study (PMS)

NCT06189365 | Terminated Results FDA Device

• 2 other identifiers: ABT-CIP-10491CRD_1028
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Non-Valvular Atrial Fibrillation

Keywords

Non-Valvular Atrial Fibrillation; NVAF; Amplatzer Amulet

Outcome Measures

Primary Outcomes (3)

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

  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.

  7 days

• 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

  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.

  2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.)

• Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism

  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.

  2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.)

Other Outcomes (4)

• 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

  5 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.)

• Descriptive Endpoint: Rate of Device Success

  During implant procedure, approximately 30 to 60 minutes

• Descriptive Endpoint: Rate of Device Closure

  3 months

Study Arms (1)

Amulet Left Atrial Appendage Occluder

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

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

Interventions

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.

Amulet Left Atrial Appendage Occluder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years of age or older at the time of enrolment

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518009, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Xiangya Hospital Zhuzhou Central South University

Zhuzhou, Hunan, 412007, China

Location

Xianyang Hospital Of Yan'an University

Xianyang, Shaanxi, China

Location

Results Point of Contact

• Title: Associate Clinical Program Director
• Organization: Abbott

ryan.gage@abbott.com

+1 612 805 6398

Study Officials

• Zhihui ZHANG

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: January 30, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)