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 PFOTHE PROOF STUDY – Occ2019_01 –
- Conditions
- Q24Other congenital malformations of heart
- Registration Number
- DRKS00025198
- Lead Sponsor
- Occlutech International AB Landskronavägen 2
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 574
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
- 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
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the safety and tolerability of the Occlutech PFO Occluder in the 1 year following implantation.<br>Effectiveness<br>To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic stroke in the 5 years following implantation.<br>The effectiveness will be shown by assessing non-inferiority of the rate in relation to a limit derived from the rate found in historical data [1-4].
- Secondary Outcome Measures
Name Time Method • To determine the short- and medium-term safety and tolerability of the Occlutech PFO Occluder <br>• To determine the short- and medium-term effectiveness of the Occlutech PFO Occluder<br>• To determine the technical and procedural success rate