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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02882815
Other study ID # PFO-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date January 2017

Study information

Verified date August 2018
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date January 2017
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
IrisFIT PFO Occluder


Locations

Country Name City State
Germany Cardio Vasculäres Centrum Frankfurt Frankfurt
Germany Helmut-G.-Walther-Klinikum Lichtenfels
Ireland Mater Misericordiae University Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Countries where clinical trial is conducted

Germany,  Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Device related adverse event up to 1 month follow-up Device related adverse event up to 1 month follow-up 1 month post procedure
Primary Device related adverse event up to 12 month follow-up Device related adverse event up to 12 month follow-up 12 month post procedure
Primary Rate of accurate device placement Rate of accurate device placement 6 month post procedure
Primary Incidence of device migration/malfunction Incidence of device migration/malfunction 6 month post procedure
Primary 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
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