ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 721
- 试验地点
- 1
- 主要终点
- MR Severity
研究概览
简要总结
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.
详细描述
PHASE I:
The primary objective of ACCESS-EU Phase I is to gain information in the European Union Countries regarding the use of the MitraClip System with respect to health economics and clinical care.
PHASE II: (HAS BEEN CLOSED BY SPONSOR) The primary objective of ACCESS-EU Phase II is to gather additional clinical data, specifically Echocardiography Core Laboratory measurements of MR severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the MitraClip procedure in the European Union Countries,
Clinical data collected from both study phases, is expected to contribute to decision making with regards to MitraClip therapy selection in patients with MR: (a) by establishing the value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.
排除标准
- •Per the current approved labeling for the CE Marked MitraClip System.
研究组 & 干预措施
MitraClip Therapy
Patients treated with the MitraClip System.
干预措施: MitraClip (Device)
Medical Management
Patients with MR managed non-surgically based on standard hospital clinical practice.
干预措施: Medical Management (Drug)
Mitral Valve Surgery
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice.
干预措施: Mitral Valve Surgery (Procedure)
结局指标
主要结局
MR Severity
时间窗: At 12 months
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
次要结局
- The Change in 6 Minute Walk Test Distance From Baseline to 12 Months(Baseline and 12 months)
- Procedure Time(Day 0 (On the day of procedure))
- Six Minute Walk Test Distance (6MWT)(12 months)
- Contrast Volume(Day 0 (On the day of procedure))
- Fluoroscopy Duration(Day 0 (On the day of procedure))
- Number of MitraClip Devices Implanted(Day 0 (On the day of procedure))
- ICU and Hospital Stay(From the day of procedure throughout 12 months of study period)
- Discharge Status and Facility(At discharge, an average of 7.7 days following the MitraClip procedure)
- Discharge MR Severity(At discharge, an average of 7.7 days following the MitraClip procedure)
- Device Embolization and Single Leaflet Device Attachment(Through 12 months)
- NYHA Functional Class(At 12 month)
- Need for Mitral Valve Surgery(Through 12 months)
- Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months(12 months)
- Kaplan-Meier Freedom From All-Cause Mortality(At 12 months)
- 1-Day Post-Procedure Safety Outcomes(On day 1 post procedure)