NCT07698951招募中不适用
Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study
Recross Cardio, Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年6月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effective PFO Closure
研究概览
简要总结
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is:
• Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.
Participants will:
- Undergo the procedure to implant the P3 Occluder System, if deemed appropriate.
- Visit their doctor at 1 month, 3 months, 6 months, and 1 year after the procedure for follow up exams.
- Answer a phone call from study staff at 2 years and 3 years after the procedure to answer a survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥ 18 and ≤ 65 years of age
- •Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release.
- •Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.
- •Modified Rankin score (mRS) ≤
- •Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.
- •Patient is willing and capable of providing informed consent.
- •Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.
排除标准
- •Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.
- •Other arteriopathy of the intracranial or extracranial vessels with >50% stenosis proximal to the territory of the index stroke.
- •Intracardiac thrombus or tumor.
- •Myocardial Infarction (MI) or unstable angina within the previous 180 days.
- •Life expectancy < 2 years.
- •Left ventricular aneurysm or akinesis.
- •Moderate to severe mitral valve stenosis or severe mitral regurgitation.
- •Aortic valve stenosis (mean gradient >20 mmHg) or severe regurgitation.
- •Active endocarditis or other infection that may preclude implantation of the investigational device.
- •Any valve vegetation or Lambl's excrescence of any left-sided valve.
- •Left ventricular dilated cardiomyopathy with LVEF <35%.
- •Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation.
- •History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.
- •Severe renal failure ( Stage 4 CKD, eGFR <30) or patient requiring dialysis.
- •Severe liver disease (e.g., documented cirrhosis or active hepatitis).
- •Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
- •Uncontrolled hypertension, defined as sustained elevated blood pressure >140/90 mm Hg.
- •Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of >50mmHg.
- •Uncontrolled hyperglycemia, defined as HbA1c value >8% (IFCC: >64 mmol/mol).
- •Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.
- •Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
- •Subjects contraindicated for aspirin or clopidogrel.
- •Subjects not able to discontinue anticoagulation for indications other than then index stroke.
- •Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).
- •Currently an active subject in an investigational drug or device study that could confound the results of this study.
- •Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
- •Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
- •Any prior percutaneous cardiovascular intervention for AF ablation.
- •Known nickel allergy that, in the opinion of the investigator, poses a safety risk with regards to participation in the trial.
研究组 & 干预措施
Recross P3 Occluder (P3O) System
Experimental
The Recross P3 Occluder (P3O) is being developed for the purpose of transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients with PFO-associated stroke.
干预措施: Recross P3 Occluder (P3O) System (Device)
结局指标
主要结局
Effective PFO Closure
时间窗: 6 months
Effective PFO Closure, at index procedure and at 6 months as measured by TEE, as adjudicated.
Adverse Cardiovascular Events
时间窗: 30 days
Occurrence of significant adverse events including cardiac death, myocardial infarction, and stroke within 30 days post-procedure
次要结局
- Rate of device-related or procedure-related Serious Adverse Events (SAEs)(30 days; 6 months)
- Correct device position(6 months)
研究者
研究点 (1)
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