AMPLATZER™ Cardiac Plug Observational Post-Approval Study

Completed

• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Interventions: Device: AMPLATZER™ Cardiac Plug

• Registration Number: NCT02954237
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2016-11-14
• Primary Completion: 2021-01-29
• Study Completion: 2021-01-29
• Results First Submitted: 2022-03-08
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-17
• Last Update Submitted: 2022-06-17
• Results First Posted: 2022-06-24
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention	Within 7 days of the procedure	The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy	Within 2 years of the procedure	The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.
Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism	Within 2 years of the procedure	The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.

Trial Locations

Locations (6)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Sir Run Run Shaw Hospital; 🇨🇳 Zhejiang, Hangzhou, China

Ningbo First Hospital; 🇨🇳 Ningbo, Liuting Saint, China

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

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China