Implementation of a Structural Mitral Valve Clinic for the Management of Patients With Heart Failure Refractory to Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wait time 2
研究概览
简要总结
This is a prospective Quality Improvement (QI) study using the Model for Improvement framework.
The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of:
i.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities.
Patients for this study will be recruited through medical referral within the south eastern Ontario, Canada region.
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
- •All adults (≥18 years of age) patients with primary and secondary moderate to severe MR with HF (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class >II), who have had at least one previous hospitalization for HR, require specialist advisement, and have provided signed informed consent.
排除标准
- •Those who are not eligible for either an MV surgical intervention or a TMVI procedure.
- •Females of childbearing age who are not willing or unable to use a reliable method of birth control.
- •Inpatient referrals.
结局指标
主要结局
Wait time 2
时间窗: At week sixteen following study entry.
The time from acceptance for a procedure to time of pre-procedure imaging.
Wait time 1
时间窗: At week three following study entry.
The time between date referral made and date acknowledged by cardiologist.
Wait time 3
时间窗: At week sixteen following study entry.
The time from acceptance for a procedure to time of procedure.
次要结局
- Morbidity 2(At one year post procedure.)
- Mortality 1(At 30 days post procedure.)
- Mortality 2(At one year post procedure.)
- Morbidity 1(At 30 days post procedure.)
研究者
Wael Abuzeid
MD, MSc, Interventional Cardiologist, Assistant Professor, Department of Medicine
Queen's University