AMPLATZER™ Cardiac Plug Observational Post-Approval Study

NCT02954237 | Completed Results

• 2 other identifiers: SJM-CIP-CRD 881SJM-CIP-10153
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 6

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)

Keywords

Non-valvular atrial fibrillation (NVAF); Anticoagulant; Warfarin; Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

AMPLATZER™ Cardiac Plug

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

Device: AMPLATZER™ Cardiac Plug

Interventions

AMPLATZER™ Cardiac Plug 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)

AMPLATZER™ Cardiac Plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or relevant event despite taking warfarin.

You may qualify if:

• Patient who meets the current indications and per physician discretion for ACP implant
• Patient who is ≥ 18 years of age at the time of enrolment
• Patient who is able to provide written Informed Consent prior to any study related procedures

You may not qualify if:

• Patient who is unable to comply with the follow-up schedule
• Patient with the presence of intracardiac thrombus
• Patient with active endocarditis or other infections producing bacteraemia
• Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding (HAS-BLED score\<3)
• Patient where placement of the device would interfere with any intracardiac or intravascular structures
• Patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator
• Patient with LAA anatomy that does not accommodate a device per the sizing guidelines
• Patient who has a life expectancy of less than 2 years due to any condition
• Patient who are currently participating in a clinical investigation that includes an active treatment arm
• Patient who already had a left atrial appendage closure device implanted prior to the study

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Sir Run Run Shaw Hospital

Zhejiang, Hangzhou, 310016, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Ningbo First Hospital

Ningbo, Liuting Saint, 315000, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jordan Anderson, Clinical Scientist
• Organization: Abbott

ClinicalTrials.gov_SH_Inquiries@abbott.com

651-756-3360

Study Officials

• Maren Wagner

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: November 3, 2016
• Study Start: November 14, 2016
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: June 24, 2022
• Results First Posted: June 24, 2022

Record last verified: 2022-06

Locations

CN (6)