Patent Foramen Ovale Clinical Trial
— PFOOfficial title:
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)
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 |
Verified date | August 2018 |
Source | Lifetech Scientific (Shenzhen) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Cardio Vasculäres Centrum Frankfurt | Frankfurt | |
Germany | Helmut-G.-Walther-Klinikum | Lichtenfels | |
Ireland | Mater Misericordiae University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Lifetech Scientific (Shenzhen) Co., Ltd. |
Germany, Ireland,
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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