DRKS00025198进行中（未招募）不适用
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 – - PROOF
Occlutech International AB Landskronavägen 20 个研究点目标入组 574 人开始时间: 2021年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 574
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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