StrokePROOFNCT04029233
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
An observational study of Stroke and PFO - Patent Foramen Ovale, run by Occlutech International AB at 17 sites in 4 countries.
Trial summary
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, PFO - Patent Foramen Ovale
- What is being tested?
- Occlutech PFO Occluder
- Type of treatment
- Medical device
- How many people
- 582 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 3 Oct 2019to 16 Apr 2024
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll patients of either sex, aged ≥18 and ≤60 years, with at least one event of cryptogenic ischemic stroke in the last 6 months. Patients must have a high risk PFO indicated for device-assisted closure; either large PFO (≥2 mm), or PFO of any size and ASA.
Who may be able to join
- Age ≥18 years and ≤65 years
- At least one event of cryptogenic ischemic stroke in the last 12 months
- Presence of a PFO indicated for device-assisted closure (in compliance with the Instruction for Use) confirmed by common practice procedures
- A large PFO (maximum separation of the septum primum from the secundum) of ≥2 mm confirmed by common practice procedures, or an ASA defined by common practice procedures as septum primum excursion of ≥10 mm
- Life expectancy of at least 1 year
- Ability to speak fluently and to understand the language in which the study is being conducted
- Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
Who cannot join
- Acute infection(s)
- Known coagulation disorder
- Arrhythmia
- Atrial Tumor
- Allergies to nickel and/or titanium and/or nickel/titanium-related material
- Inability to achieve adequate oral anticoagulation therapy and/or platelet inhibition post intervention
Show all 30Show fewer
- Intolerance to contrast agents
- Participation in another clinical investigation <30 days before intended Occlutech PFO Occluder implantation procedure (note that in line with Medical Device Reporting, registries are not considered as clinical investigations)
- Contraindication to use of trans-esophageal echocardiography (TEE) and/or use of general anesthetic
- Eisenmenger Syndrome
- Recent pelvic venous thrombosis
- Myocardial infarction or coronary artery bypass surgery within the last 30 days
- Atrial thrombus
- Patients whose size or condition would cause them to be a poor candidate for cardiac catheterization (e.g. too small for echocardiography imaging probe, catheter size, vasculature size, active infection, body weight <8 kg)
- The following exclusion criteria are at the discretion of the investigator:
- Stroke of any other origin
- Large artery atherosclerosis
- Small vessel disease
- Arterial dissection
- Hypercoagulable disorder
- Uncontrolled hypertension
- Uncontrolled diabetes
- Autoimmune disease
- Evidence of drug or alcohol abuse
- Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
- End-stage heart-, liver-, lung-, or kidney disease
- Cardiac tumor
- Endocarditis or septicemia
- Severe valvular pathology
- Any condition that, in the opinion of the investigator, might interfere with the implantation,might affect the patients' well-being thereafter or might interfere with the conduct of the study
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Germany11 sites
Charité Universität Berlin
Berlin
Herzzentrum Bremen
Bremen
Klinikum Coburg
Coburg
Herzzentrum der Universität zu Köln
Cologne
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
Dresden
Universitätsklinikum Düsseldorf
Düsseldorf
CardioVasculäres Centrum Frankfurt
Frankfurt
Uniklinik Freiburg
Freiburg im Breisgau
Asklepios Klinik Hamburg
Hamburg
Uniklinik Heidelberg
Heidelberg
University Jena
Jena
France4 sites
CHU Clermont-Ferrand
Clermont-Ferrand
Institut de Cardiologie,groupe hospitalier pitié salpêtrière
Paris
New Civil Hospital
Strasbourg
CHU Rangueil
Toulouse
About this study
Official title: Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Read the detailed description
This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
- Conditions
- Stroke, PFO - Patent Foramen Ovale
- Being tested
- Occlutech PFO Occluder
- Medical subject headings
- Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlutech PFO OccluderDevice
Also called Occlutech Figulla Flex II Occluder
The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs.
Measured: in the 1 year following implantation.
To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes.
Measured: in the 5 years following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start3 Oct 2019
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Why it stopped: Not due to safety concerns,high procedure success rate,6mo closure rate 94.2%,rate of SADE1.1%, 12mo rcurrent stroke rate 0.8%.Concurrent OCCLUFLEX trial+projected completion earlier than PROOF FU,no need to demonstrate add.level of efficacy evidence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029233
- Sponsor's protocol ID
- Occ2019_01
- Acronym
- PROOF
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
- ClinicalTrials.gov ID
- NCT04029233
- Acronym / sponsor ID
- PROOF / Occ2019_01
- Conditions
- Stroke, PFO - Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not due to safety concerns,high procedure success rate,6mo closure rate 94.2%,rate of SADE1.1%, 12mo rcurrent stroke rate 0.8%.Concurrent OCCLUFLEX trial+projected completion earlier than PROOF FU,no need to demonstrate add.level of efficacy evidence
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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.
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Detailed description
This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients of either sex, aged ≥18 and ≤60 years, with at least one event of cryptogenic ischemic stroke in the last 6 months. Patients must have a high risk PFO indicated for device-assisted closure; either large PFO (≥2 mm), or PFO of any size and ASA.
Key inclusion criteria (7 listed)
- Age ≥18 years and ≤65 years
- At least one event of cryptogenic ischemic stroke in the last 12 months
- Presence of a PFO indicated for device-assisted closure (in compliance with the Instruction for Use) confirmed by common practice procedures
- A large PFO (maximum separation of the septum primum from the secundum) of ≥2 mm confirmed by common practice procedures, or an ASA defined by common practice procedures as septum primum excursion of ≥10 mm
- Life expectancy of at least 1 year
Key exclusion criteria (30 listed)
- Acute infection(s)
- Known coagulation disorder
- Arrhythmia
- Atrial Tumor
- Allergies to nickel and/or titanium and/or nickel/titanium-related material
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 |
|---|---|---|
| Occlutech PFO OccluderAlso: Occlutech Figulla Flex II OccluderThe Occlutech PFO Occluder is a medical device for transcatheter closure of PFO. | Device | – |
Primary outcome
To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs.
Time frame: in the 1 year following implantation.
To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes.
Time frame: in the 5 years following implantation
Results and safety
The study was stopped early (reason given: Not due to safety concerns,high procedure success rate,6mo closure rate 94.2%,rate of SADE1.1%, 12mo rcurrent stroke rate 0.8%.Concurrent OCCLUFLEX trial+projected completion earlier than PROOF FU,no need to demonstrate add.level of efficacy evidence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and PFO - Patent Foramen Ovale, run by Occlutech International AB at 17 sites in 4 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 7 inclusion and 30 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, France, Canada, Italy. 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 was stopped early (reason given: Not due to safety concerns,high procedure success rate,6mo closure rate 94.2%,rate of SADE1.1%, 12mo rcurrent stroke rate 0.8%.Concurrent OCCLUFLEX trial+projected completion earlier than PROOF FU,no need to demonstrate add.level of efficacy evidence). Results are not available in the source record.
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?
To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs. (time frame: in the 1 year following implantation.). The study lists 2 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 19 Sep 2024.