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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 (PROOF)

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ClinicalTrials.gov Identifier: NCT04029233
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

Brief 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.

Condition or disease Intervention/treatment
Stroke PFO - Patent Foramen Ovale Device: Occlutech PFO Occluder

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).

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Study Type : Observational
Estimated Enrollment : 863 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2026

Intervention Details:
  • Device: Occlutech PFO Occluder
    The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
    Other Name: Occlutech Figulla Flex II Occluder


Primary Outcome Measures :
  1. 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. ]
  2. 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 ]


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:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Age ≥18 years and ≤60 years
  • At least one event of cryptogenic ischemic stroke in the last 6 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

Exclusion Criteria:

  • Acute infection(s)
  • Known coagulation disorder
  • Allergies to nickel and/or titanium and/or nickel/titanium-related material, if not medically manageable
  • Inability to achieve adequate oral anticoagulation therapy and/or platelet inhibition post intervention
  • Intolerance to contrast agents, if not medically manageable
  • 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

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): NCT04029233


Contacts
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Contact: Gönül Sönmez Utkun +90 2124650497 clinicaltrials@occlutech.com

Locations
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Canada
St. Paul's Hospital Recruiting
Vancouver, Canada
Contact: Carere Ronald, Dr         
Germany
Klinikum Coburg Recruiting
Coburg, Germany
Contact: Steffen Schnupp, Dr         
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden Recruiting
Dresden, Germany
Contact: Felix Woitek, Dr.         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Tobias Zeus, Dr         
CardioVasculäres Centrum Frankfurt Recruiting
Frankfurt, Germany
Contact: Horst Sievert, Prof         
Herzzentrum der Universität zu Köln Recruiting
Köln, Germany
Contact: Roman Pfister, Prof         
Italy
Centro Cardiologico Monzino Recruiting
Milan, Italy
Contact: Daniela Trabattoni, Dr         
Sponsors and Collaborators
Occlutech International AB
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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT04029233    
Other Study ID Numbers: Occ2019_01
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Foramen Ovale, Patent
Recurrence
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities