The CLASP III TR CED Study
Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
研究概览
地位
详细说明
This is a prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system ("PASCAL Precision system") for the treatment of at least severe tricuspid regurgitation in the real world.
This study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and other claims data.
The primary outcome will also be assessed in various pre-defined subgroups.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：TMTT GHER
- 电话号码：949-250-2500
- 邮箱：TMTT_GHER_Evidence@edwards.com
学习地点
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California
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Irvine、California、美国、92614
- Edwards Lifesciences
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接触：
- TMTT GHER
- 电话号码：949-250-2500
- 邮箱：TMTT_GHER_EVIDENCE@edwards.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Medicare eligible real-world patients with severe tricuspid regurgitation
描述
Inclusion Criteria:
- Medicare eligible patients, 65 years old or older
- With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention
Exclusion Criteria:
- Patients not eligible for Medicare (i.e., under 65 years old)
- Patients with less than severe Tricuspid Regurgitation
- Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
PASCAL Precision system Treated
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. |
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. |
|
Medicare Eligible Untreated Patients
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. |
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite (All-Cause Death or Heart Failure Hospitalization)
大体时间：2 years
|
Time to death or heart failure hospitalization after time zero |
2 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.