AMPLATZER™ Cardiac Plug Observational Post-Approval Study

NCT ID: NCT02954237

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2021-01-29

Brief Summary

The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single arm, post approval, observational study. The clinical study will be conducted at up to 35 sites in China. Approximately 343 subjects will be enrolled in this study.

The total study duration is expected to be approximately 7 years. The study population included patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin.

Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

AMPLATZER™ Cardiac Plug

Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.

AMPLATZER™ Cardiac Plug

Intervention Type: DEVICE

The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)

Interventions

AMPLATZER™ Cardiac Plug

The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient who meets the current indications and per physician discretion for ACP implant

2. Patient who is ≥ 18 years of age at the time of enrolment

3. Patient who is able to provide written Informed Consent prior to any study related procedures

Exclusion Criteria

1. Patient who is unable to comply with the follow-up schedule

2. Patient with the presence of intracardiac thrombus

3. Patient with active endocarditis or other infections producing bacteraemia

4. Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score<3)

5. Patient where placement of the device would interfere with any intracardiac or intravascular structures

6. Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator

7. Patient with LAA anatomy that does not accommodate a device per the sizing guidelines

8. Patient who has a life expectancy of less than 2 years due to any condition

9. Patient who are currently participating in a clinical investigation that includes an active treatment arm

10. Patient who already had a left atrial appendage closure device implanted prior to the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maren Wagner

Role: STUDY_DIRECTOR

Abbott

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Sir Run Run Shaw Hospital

Zhejiang, Hangzhou, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Ningbo First Hospital

Ningbo, Liuting Saint, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10153

Identifier Type: OTHER

Identifier Source: secondary_id

SJM-CIP-CRD 881

Identifier Type: -

Identifier Source: org_study_id