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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
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Device: IrisFIT PFO Occluder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Rate of accurate device placement [ Time Frame: 6 month post procedure ]
    Rate of accurate device placement

  5. Incidence of device migration/malfunction [ Time Frame: 6 month post procedure ]
    Incidence of device migration/malfunction

  6. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Germany
Cardio Vasculäres Centrum Frankfurt
Frankfurt, Germany
Helmut-G.-Walther-Klinikum
Lichtenfels, Germany
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
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Principal Investigator: HORST SIEVERT CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY
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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02882815    
Other Study ID Numbers: PFO-01
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
IrisFIT PFO
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities