NCT02882815

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

August 3, 2016

Last Update Submit

August 7, 2018

Conditions

Patent Foramen Ovale

Keywords

IrisFIT PFO

Outcome Measures

Primary Outcomes (6)

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

    Device related adverse event up to 1 month follow-up

    1 month post procedure

  • Device related adverse event up to 12 month follow-up

    Device related adverse event up to 12 month follow-up

    12 month post procedure

  • Rate of accurate device placement

    Rate of accurate device placement

    6 month post procedure

  • Incidence of device migration/malfunction

    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).

    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

Study Arms (1)

IrisFIT PFO Occluder

OTHER

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.

Device: IrisFIT PFO Occluder

Interventions

IrisFIT PFO OccluderDEVICE
IrisFIT PFO Occluder

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardio Vasculäres Centrum Frankfurt

Frankfurt, Germany

Location

Helmut-G.-Walther-Klinikum

Lichtenfels, Germany

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • HORST SIEVERT

    CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 30, 2016

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

January 1, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

DE(2)IE(1)