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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04029233
Other study ID # Occ2019_01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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