Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mortality Rate
研究概览
简要总结
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).
详细描述
TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And
- •Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).
排除标准
- •Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
- •Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
研究组 & 干预措施
No AHI
Patients undergoing TTVR without presenting any AHI post-procedurally
AHI
Patients undergoing TTVR and presenting AHI within 24h after the procedure
结局指标
主要结局
Mortality Rate
时间窗: 1 Year
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.
次要结局
- Number of Participants with Coronary Artery Disease (CAD)(Baseline (Day 0))
- Number of Participants with Right Ventricular (RV) Dysfunction(Baseline (Day 0))
- Number of Participants with Pulmonary Hypertension(Baseline (Day 0))
- Number of Participants with Primary Left Ventricular Cardiomyopathy(Baseline (Day 0))
- Number of Participants with Post-Procedural Fever(Within 48 hours after the procedure)
- Number of Participants with Post-procedural Inflammatory Response(Within 48 hours after the procedure)
- Number of Participants with AHI(Within 24 hours after the procedure)