Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- All - cause rehospitalisation after completion of procedure
研究概览
简要总结
Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.
Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.
This prospective, observational cohort study will examine the safety and feasibility of this practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Aged ≥18 years
- •Accepted by Heart Team for TEER (mitral and/or tricuspid)
- •Willing and able to give informed consent for participation in the study.
- •Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography
- •Patient is willing and able to attend all follow-up visits
排除标准
- •Patients in whom safety or clinical concerns preclude participation
- •Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent)
- •Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful
- •Pregnant or planning pregnancy within next 12 months
- •Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- •Patients requiring emergency TEER
结局指标
主要结局
All - cause rehospitalisation after completion of procedure
时间窗: 30 days, 1 year
Any hospital admission after discharge from the index procedure
All cause death after completion of procedure
时间窗: 30 days, 1 year
All patient death following discharge after the index procedure
Proportion of patients discharged 'early' after edge -to-edge repair
时间窗: up to 30 days
defined as \< 36 hours after completion of procedure
次要结局
- Hospital length of stay(Up to 3 months)
- Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days(During index admission up to 30 days post procedure.)
- Proportion of patients requiring intensive care unit care(Up to 3 months)
- Heart failure hospitalisation(30 days, 1 year)
- Symptomatic improvement(3 months, 1 year)
研究者
Sam Dawkins
Primary Investigator
Oxford University Hospitals NHS Trust