NCT05077774进行中（未招募）不适用
Harmony TPV Post-Approval Study (Harmony PAS2)
Medtronic Cardiovascular39 个研究点 分布在 2 个国家目标入组 174 人开始时间: 2021年10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
- 进行中（未招募）
- 发起方
- 入组人数
- 174
- 试验地点
- 39
- 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 purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
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
- •Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
- •Patient (or patient's legally authorized representative) is willing to consent to participate in the study
排除标准
- •Obstruction of the central veins
- •Planned concomitant branch pulmonary artery stenting at time of implant
- •Subject is pregnant at time of implant procedure
- •Patients with 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
研究组 & 干预措施
Harmony TPV System
Other
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
干预措施: Harmony TPV System (Device)
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
- Percentage of subjects free from catheter reintervention at 6-months(6 months)
- Number and percentage of subjects with serious device-related adverse events at 6 months(6 months)
- Percentage of subjects free from all-cause mortality 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)
- Percentage of subjects free from reoperation at 6-months(6 months)
研究者
研究点 (39)
Loading locations...
相似试验
进行中（未招募）
不适用
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical StudyPulmonary RegurgitationTetrology of FallotRVOT AnomalyCongenital Heart DiseaseNCT02979587Medtronic Heart Valves86
已完成
不适用
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII BSevereSymptomaticCalcific Aortic StenosisNCT02184442Edwards Lifesciences560
已完成
不适用
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THVPulmonary RegurgitationPulmonary Valve InsufficiencyDysfunctional RVOT ConduitPulmonary ObstructionPulmonary StenosisNCT00676689Edwards Lifesciences81
已完成
不适用
Melody® Transcatheter Pulmonary Valve Post-Approval StudyDysfunctional Right Ventricular Outflow Tract (RVOT) ConduitNCT01186692Medtronic Cardiovascular131
Unknown
不适用
SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data CollectionBi-ventricular FailureNCT01919320SynCardia Systems. LLC500