NCT05045079已完成不适用
Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in KCCQ QOL scores
研究概览
简要总结
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
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
- 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
- •Age ≥ 18 years.
- •Moderate-severe or severe TR while in atrial fibrillation.
- •Ambulatory (not wheelchair/scooter dependent).
排除标准
- •Systolic pulmonary artery pressure>70 mmHg with a fixed pulmonary vascular resistance >7 Wood units by catheterization.
- •Ejection fraction <40%.
- •Obstructive hypertrophic cardiomyopathy.
- •Constrictive pericarditis or tamponade.
- •Active myocarditis.
- •Complex congenital heart disease.
- •Other valve disease requiring surgical intervention.
- •Terminal illness (other than HF) with expected survival of less than 1 year.
- •Pregnancy or breastfeeding mothers.
结局指标
主要结局
Change in KCCQ QOL scores
时间窗: Baseline, 6 months
The KC Cardiomyopathy Questionnaire (0-100 scale) assess subject perception of heart failure limitation on their life; scale of extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, limited for other reasons or did not do the activity.
次要结局
未报告次要终点
研究者
研究点 (2)
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