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

August 7, 2018 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frankfurt, Germany
        • Cardio Vasculäres Centrum Frankfurt
      • Lichtenfels, Germany
        • Helmut-G.-Walther-Klinikum
      • Dublin, Ireland
        • Mater Misericordiae University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: IrisFIT PFO Occluder
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during completion of the procedure
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
1 month post procedure
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
12 month post procedure
Rate of accurate device placement
Time Frame: 6 month post procedure
Rate of accurate device placement
6 month post procedure
Incidence of device migration/malfunction
Time Frame: 6 month post procedure
Incidence of device migration/malfunction
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).
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).
6 month post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: HORST SIEVERT, CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (ESTIMATE)

August 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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