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

Stroke Clinical Trial

— PROOF  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04029233
• Other study ID #: Occ2019_01
• Status: Active, not recruiting
• Start date: October 3, 2019
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Occlutech International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 570
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Stroke
• PFO - Patent Foramen Ovale
• Recurrence
• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Institut de Cardiologie,groupe hospitalier pitié salpêtrière	Paris
France	New Civil Hospital	Strasbourg
France	CHU Rangueil	Toulouse
Germany	Charité Universität Berlin	Berlin
Germany	Herzzentrum Bremen	Bremen
Germany	Klinikum Coburg	Coburg
Germany	Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	CardioVasculäres Centrum Frankfurt	Frankfurt
Germany	Uniklinik Freiburg	Freiburg
Germany	Asklepios Klinik Hamburg	Hamburg
Germany	Uniklinik Heidelberg	Heidelberg
Germany	University Jena	Jena
Germany	Herzzentrum der Universität zu Köln	Köln
Italy	Centro Cardiologico Monzino	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Canada,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs.		in the 1 year following implantation.
Primary	To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes.		in the 5 years following implantation