A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 29
- 主要终点
- Primary endpoint
研究概览
简要总结
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically significant mitral or aortic paravalvular leaks after previously implanted prosthetic heart valves who undergo transcatheter PVL closure in routine clinical practice. Up to 200 subjects are planned to be enrolled and followed after the procedure (Day 1-7, Day 30, 6-12 months, and annually up to 3 years) to evaluate device safety (including serious adverse device effects) and effectiveness, including reduction of paravalvular regurgitation assessed by echocardiography and clinical outcomes such as improvement in heart failure symptoms and/or reduced need for hemolysis-related transfusions.
详细描述
International, multicenter, observational post-marketing follow-up registry evaluating real-world use of transcatheter paravalvular leak (PVL) closure with the Occlutech Paravalvular Leak Device (PLD) in adult patients with clinically significant mitral or aortic PVL after prior prosthetic heart valve implantation. The registry includes retrospective and prospective data collection across participating sites and follows patients for up to 3 years to characterize longer-term safety and clinical performance of PVL closure with the device in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meeting the indication and area of application of the PLD device as laid down in the IFU.
- •The Occlutech® PLD is indicated for patients with a significant leak that causes hemodynamically significant heart failure or hemolysis which requires recurrent blood transfusions. It is further indicated for patients who are deemed at high risk for surgery after consultation with the surgeon or as an alternative to surgery with less operational time and recovery period.
- •Male of female patients
- •Patients of age ≥ 18 years
- •Patients understanding the nature of the study and providing their informed consent to participation.
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
排除标准
- •Contraindications as described in the IFU:
- •Acute infection or any serious infection 1 month prior to procedure
- •Adequate oral anti-coagulation therapy / platelet inhibition is not possible post-intervention.
- •Allergies to nickel and/or titanium and/or nickel/titanium-based materials
- •Intolerance to contrast agents
- •Known coagulation disorder
- •Known intra-cardiac thrombus
- •Recent pelvic venous thrombosis
- •Recent myocardial infarction or a surgical bypass operation in the last 30 days Note: a positive result to a pregnancy test necessitates the exclusion of the subject from the registry.
结局指标
主要结局
Primary endpoint
时间窗: 1 year
Primary endpoint The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects, including, but not limited to major cardiac arrhythmia (ventricular tachycardia/VF), procedure-related death, procedure-related stroke, rehospitalizations, systemic embolism, severe hemolysis, device embolization, infective endocarditis, prosthetic impingement, valvular regurgitation or vascular complications requiring surgery up to 1-year post-implantation, during the procedure new or worsening prothesis dysfunction, coronary obstruction, transfusion requirement, conversion to open surgery or unplanned intervention The primary efficacy endpoint is defined as successful implantation of the PLD device with the recommended accessories and delivery system with effective closure of the paravalvular leak (defined as reduction in paravalvular regurgitation of ≥1 grade leak36 , presence of a residual PVL greater than mild as assessed by echocardiography post implantation FUP,
次要结局
- Secondary endpoint(3 year)