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

NCT ID: NCT02882815

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Patent Foramen Ovale

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

IrisFIT PFO Occluder

Intervention Type: DEVICE

Interventions

IrisFIT PFO Occluder

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HORST SIEVERT

Role: PRINCIPAL_INVESTIGATOR

CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY

Locations

Cardio Vasculäres Centrum Frankfurt

Frankfurt, , Germany

Helmut-G.-Walther-Klinikum

Lichtenfels, , Germany

Mater Misericordiae University Hospital

Dublin, , Ireland

Countries

Germany; Ireland

Other Identifiers

PFO-01

Identifier Type: -

Identifier Source: org_study_id