Clinical trial NCT02882815: Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
Official title: Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Foramen Ovale
Keywords: IrisFIT PFO
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse device effects during the procedure up to the point of implanting the study device in the PFO, and during completion of the procedure
timeFrame: during completion of the procedure
measure: Device related adverse event up to 1 month follow-up
timeFrame: 1 month post procedure
measure: Device related adverse event up to 12 month follow-up
timeFrame: 12 month post procedure
measure: Rate of accurate device placement
timeFrame: 6 month post procedure
measure: Incidence of device migration/malfunction
timeFrame: 6 month post procedure
measure: Successful closure/procedure rate: Proper position of the occluder by imaging, with trivial to small or without residual shunt, 6 month after procedure).
timeFrame: 6 month post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Cardio Vasculäres Centrum Frankfurt
city: Lichtenfels
country: Germany
facility: Helmut-G.-Walther-Klinikum
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
affiliation: CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY
name: HORST SIEVERT
role: PRINCIPAL_INVESTIGATOR
References: