Harmony TPV EMEA Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 23
- 主要终点
- Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
研究概览
简要总结
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.
详细描述
Prospective, non-randomized, multi-center, post-market interventional clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.
- •Subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements
排除标准
- •Obstruction of the central veins.
- •Planned concomitant branch pulmonary artery stenting at time of implant.
- •Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.
- •A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.
- •Planned implantation of the Harmony TPV in the left heart.
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- •Pre-existing prosthetic heart valve or prosthetic ring in any position
- •Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.
- •Subjects that are vulnerable as defined in the Section 10.5 Subject Consent
- •Subject Consent Section excerpt:
- •Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.
- •Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.
研究组 & 干预措施
Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment
The Harmony TPV implant as per Standard of Care
干预措施: Certain imaging assessments can be non-Standard of Care (Radiation)
结局指标
主要结局
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
时间窗: 6 months
* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%
次要结局
- Number and percentage of subjects with serious device-related adverse events at 6 months(6 months)
- Percentage of subjects free from catheter reintervention at 6-months(6 months)
- Percentage of subjects free from all-cause mortality at 6-months(6 months)
- Percentage of subjects free from reoperation at 6-months(6 months)
- Percentage of subjects free from TPV dysfunction at 6-months(6 months)
- Number and percentage of subjects with procedure success at 30-days(30 days)