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Amplatzer PFO Occluder Post-marketing Surveillance Study (PFO PMS Jpn)

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: NCT04349995
Recruitment Status : Active, not recruiting
First Posted : April 16, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Condition or disease Intervention/treatment
PFO - Patent Foramen Ovale Device: Amplatzer PFO Occluder

Detailed Description:
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amplatzer PFO Occluder Post-marketing Surveillance Study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : May 28, 2026

Group/Cohort Intervention/treatment
Amplatzer PFO Occluder
Percutaneous PFO Closure using Amplatzer PFO occluder
Device: Amplatzer PFO Occluder
Percutaneous PFO closure using Amplatzer PFO Occluder




Primary Outcome Measures :
  1. device- or procedure related SAE rate [ Time Frame: up to 30 Days ]
    device- or procedure related serious adverse events (SAEs) through 30 days

  2. PE, DVT and ischemic stroke and atrial fibrillation rate [ Time Frame: beyond 30 days through 3 years ]
    rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years

  3. Effective PFO closure [ Time Frame: At 1 year ]
    Effective closure of the PFO at 1 year



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body
Criteria

Inclusion Criteria:

  • Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

  • Refer to Amplatzer PFO occluder IFU

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349995


Locations
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Japan
Abbott Medical Japan LLC
Mita, Minato, Japan, 108-6304
Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04349995    
Other Study ID Numbers: ABT-CIP-10278
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities