Patent Foramen OvalePFONCT02882815
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder
A study testing IrisFIT PFO Occluder in people with Patent Foramen Ovale, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- IrisFIT PFO Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Cardio Vasculäres Centrum Frankfurt
Frankfurt
Helmut-G.-Walther-Klinikum
Lichtenfels
About this study
Official title: Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)
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.
Read the 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.
- Conditions
- Patent Foramen Ovale
- Being tested
- IrisFIT PFO Occluder
- Keywords
- IrisFIT PFO
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrisFIT PFO OccluderDevice
| Study group | Role | What they receive |
|---|---|---|
| IrisFIT PFO Occluder | Other | 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. Receives: Device: IrisFIT PFO Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during completion of the procedure
Device related adverse event up to 1 month follow-up
Device related adverse event up to 1 month follow-up
Measured: 1 month post procedure
Device related adverse event up to 12 month follow-up
Device related adverse event up to 12 month follow-up
Measured: 12 month post procedure
Rate of accurate device placement
Rate of accurate device placement
Measured: 6 month post procedure
Incidence of device migration/malfunction
Incidence of device migration/malfunction
Measured: 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).
Successful closure/procedure rate: Proper position of the occluder by imaging, with trivial to small or without residual shunt, 6 month after procedure).
Measured: 6 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HORST SIEVERT, Principal investigator, CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882815
- Sponsor's protocol ID
- PFO-01
- Acronym
- PFO
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale)
- ClinicalTrials.gov ID
- NCT02882815
- Acronym / sponsor ID
- PFO / PFO-01
- Conditions
- Patent Foramen Ovale
- Keywords
- IrisFIT PFO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IrisFIT PFO Occluder | Other | Device: IrisFIT PFO OccluderParticipating 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrisFIT PFO Occluder | Device | IrisFIT PFO Occluder |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HORST SIEVERT principal investigator
CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IrisFIT PFO Occluder in people with Patent Foramen Ovale, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: during completion of the procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.