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Completed

NCT Number: NCT02882815

Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder

The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.

Patients will undergo routine examination, procedure and follow-up. Related data will be collected and kept in a way that patient info is well protected.

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Key information

Conditions

Patent Foramen Ovale Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardio Vasculäres Centrum Frankfurt, Frankfurt, Germany

Loading trial locations.

About this study

This is a Post Market Clinical Follow-up study. Informed consent will be obtained from the patient or from a legally authorized representative of the patient at screening. The patients will be screened (pre-procedure) to determine eligibility for the study. At screening, patients will be assessed for study eligibility by the inclusion/exclusion criteria through their medical history, demographics and transthoracic echocardiography (TTE). Participating patients will have their PFO closed using the IrisFITTM PFO Occluder device. The patients will undergo a clinical examination, electrocardiogram (ECG), clinical laboratory assessment and transthoracic echocardiography (TTE). All periprocedural procedures will be performed according to site´s standard of care.. The efficacy and safety of the devices will be assessed by ECGs, vital signs, physical examination and TTE, which will be done at 1day, at 1month and at 6 months post procedure. Safety will also be assessed at 12 months by telephone visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are according to current international or local guidelines (and future revisions) and per physician discretion scheduled for interventional treatment of PFO.
  • Patients who are willing and capable of providing informed consent and participating in all testing/or follow procedure associated with this study.
  • Patients who are eligible for treatment with IrisFIT PFO occluder device. (Per physician discretion and device IFU).

Exclusion criteria

  • PFO tunnel length <1 mm
  • Women of childbearing potential who are or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
  • Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

Treatment and study plan

IrisFIT PFO Occluder

Device

Primary outcomes

  1. Adverse device effects during the procedure up to the point of implanting the study device in the PFO, and during completion of the procedure

    Time frame: during completion of the procedure

    Adverse device effects during the procedure up to the point of implanting the study device in the PFO, and during completion of the procedure

  2. Device related adverse event up to 1 month follow-up

    Time frame: 1 month post procedure

    Device related adverse event up to 1 month follow-up

  3. Device related adverse event up to 12 month follow-up

    Time frame: 12 month post procedure

    Device related adverse event up to 12 month follow-up

  4. Rate of accurate device placement

    Time frame: 6 month post procedure

    Rate of accurate device placement

  5. Incidence of device migration/malfunction

    Time frame: 6 month post procedure

    Incidence of device migration/malfunction

  6. Successful closure/procedure rate: Proper position of the occluder by imaging, with trivial to small or without residual shunt, 6 month after procedure).

    Time frame: 6 month post procedure

    Successful closure/procedure rate: Proper position of the occluder by imaging, with trivial to small or without residual shunt, 6 month after procedure).

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)

Acronym: PFO

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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