Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder (PFO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02882815|
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Patent Foramen Ovale||Device: IrisFIT PFO Occluder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||January 2017|
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.
Device: IrisFIT PFO Occluder
- Adverse device effects during the procedure up to the point of implanting the study device in the PFO, and during completion of the procedure [ Time Frame: 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
- Device related adverse event up to 1 month follow-up [ Time Frame: 1 month post procedure ]Device related adverse event up to 1 month follow-up
- Device related adverse event up to 12 month follow-up [ Time Frame: 12 month post procedure ]Device related adverse event up to 12 month follow-up
- Rate of accurate device placement [ Time Frame: 6 month post procedure ]Rate of accurate device placement
- Incidence of device migration/malfunction [ Time Frame: 6 month post procedure ]Incidence of device migration/malfunction
- Successful closure/procedure rate: Proper position of the occluder by imaging, with trivial to small or without residual shunt, 6 month after procedure). [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882815
|Cardio Vasculäres Centrum Frankfurt|
|Mater Misericordiae University Hospital|
|Principal Investigator:||HORST SIEVERT||CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY|