AMPLATZER™ Cardiac Plug Observational Post-Approval Study

Non-valvular Atrial Fibrillation (NVAF) Clinical Trial

— ACP China  

Official title:

AMPLATZER™ Cardiac Plug Observational Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954237
• Other study ID #: SJM-CIP-CRD 881
• Secondary ID: SJM-CIP-10153
• Status: Completed
• Start date: November 14, 2016
• Est. completion date: January 29, 2021

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation (NVAF)

Intervention

Device:
• 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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Liuting Saint
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Sir Run Run Shaw Hospital	Zhejiang	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention	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.	Within 7 days of the procedure
Primary	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	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.	Within 2 years of the procedure
Primary	Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism	The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.	Within 2 years of the procedure