Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 50
研究概览
简要总结
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is:
Does the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline.
Participants undergoing tricuspid repair and fulfilling all inclusion/exclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participants of age ≥ 18 years
- •≥ severe tricuspid regurgitation
- •LVEF < 50%
- •Written informed consent of the patient or her/his legal representative
- •Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
- •Planned follow-up within a dedicated heart failure clinic as part of routine care.
排除标准
- •Anatomy unsuitable for TEER as determined by local heart team
- •severe mitral regurgitation (defined as an EROA>40 mm2) treated (surgically or percutaneously) less than 3 months prior
- •severe left ventricular dysfunction (defined as an LVEF <20%)
- •systolic pulmonary artery pressure >70 mmHg (right heart catheterization)
- •prior tricuspid valve intervention
- •severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement
- •primary tricuspid valve disease
- •COPD requiring home oxygen therapy
- •active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy
- •participants with unstable hemodynamic condition
- •significant co-morbidities resulting in an expected less than 12-month life expectancy
- •The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up.
- •Participants under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
- •Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol