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

NCT04029233 | Terminated

• 1 other identifier: Occ2019_01
• Study Type: observational
• Target: 582
• Locations: 4 countries
• Sites: 17

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.

Conditions

Stroke; PFO - Patent Foramen Ovale

Outcome Measures

Primary Outcomes (2)

• To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs.

  in the 1 year following implantation.

• To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes.

  in the 5 years following implantation

Interventions

Occlutech PFO Occluder DEVICE

The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.

Also known as: Occlutech Figulla Flex II Occluder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• Stroke of any other origin

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (17)

St. Paul's Hospital

Vancouver, Canada

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Institut de Cardiologie,groupe hospitalier pitié salpêtrière

Paris, France

Location

New Civil Hospital

Strasbourg, France

Location

CHU Rangueil

Toulouse, France

Location

Charité Universität Berlin

Berlin, Germany

Location

Herzzentrum Bremen

Bremen, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

Herzzentrum der Universität zu Köln

Cologne, Germany

Location

Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

CardioVasculäres Centrum Frankfurt

Frankfurt, Germany

Location

Uniklinik Freiburg

Freiburg im Breisgau, Germany

Location

Asklepios Klinik Hamburg

Hamburg, Germany

Location

Uniklinik Heidelberg

Heidelberg, Germany

Location

University Jena

Jena, Germany

Location

Centro Cardiologico Monzino

Milan, Italy

Location

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: October 3, 2019
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (1); FR (4); DE (11); IT (1)