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AMPLATZER™ Cardiac Plug Observational Post-Approval Study (ACP PAS China) (ACP PAS China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954237
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
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. 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+ 2 weeks), 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.


Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation (NVAF) Device: AMPLATZER™ Cardiac Plug

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Study Type : Observational
Estimated Enrollment : 343 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: AMPLATZER™ Cardiac Plug Observational Post-Approval Study
Study Start Date : November 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)


Primary Outcome Measures :
  1. Major adverse events: Short term occurrence of death, stroke (ischemic or haemorrhagic), systemic embolism, or procedure or device-related complications requiring major cardiovascular or endovascular intervention. [ Time Frame: within 7 days after the procedure ]
  2. Long term occurrence of device related complication [ Time Frame: The next 2 years after the procedure ]
    The 2-year occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis / pericarditis), device perforation, device laceration, or device allergy.(Refer to Protect AF Study)

  3. Effectiveness [ Time Frame: The next 2 years after the procedure ]
    The 2-year rate of the composite of ischemic stroke or systemic embolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 other thromboembolic event despite taking warfarin.
Criteria

1.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.

2.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. Subject 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 already has been exposed to another investigational product
  10. Patient who already had a left atrial appendage closure device implanted prior to the study
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02954237    
Other Study ID Numbers: SJM- CIP-CRD 881
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Abbott Medical Devices:
Non-valvular atrial fibrillation (NVAF)
Anticoagulant
Warfarin
Stroke
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes