NCT03821129招募中不适用
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
W.L.Gore & Associates86 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2019年7月25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
- 636
- 试验地点
- 86
- 主要终点
- Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
研究概览
简要总结
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
详细描述
A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
- •Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
- •Patient is able to tolerate antiplatelet therapy
- •Note: Additional Inclusion Criteria may apply
排除标准
- •History of or ongoing atrial fibrillation/flutter
- •Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of <40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)
- •Previous Myocardial Infarction
- •Rankin Scale sore greater than or equal to 3 at the time of procedure
- •Active infection that cannot be treated successfully prior to enrollment
- •Neurological deficits not due to stroke that may affect the patient's neurologic assessments
- •Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
- •Sensitivity or contraindication to all proposed medical treatments or any device components
- •Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
- •Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.
- •Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
- •Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
- •Note: Additional Exclusion Criteria may apply
研究组 & 干预措施
GORE® CARDIOFORM Septal Occluder
Other
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
干预措施: PFO closure with GORE® CARDIOFORM Septal Occluder (Device)
结局指标
主要结局
Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
时间窗: 24 months
Proportion of subjects with recurrent ischemic stroke post study device implant
Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
时间窗: 30 days
Device- or procedure- related serious adverse events post study device implant
次要结局
- Clinically Significant New Atrial Arrhythmia(60 months)
- Residual Shunt Characterization via assessment of shunt in patients by Echo(24 months)
- Technical Success defined as successful delivery and retention of the GSO device based on physician reporting(Index procedure)
- Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment(12 months)
- Clinically Significant New Atrial Arrhythmia by Age(60 months)
- Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)(Enrollment through discharge, approximately 1 day)
研究者
研究点 (86)
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