Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
研究概览
简要总结
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.
详细描述
Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure.
Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications.
While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant (moderate-severe [3+] or severe [4+] secondary MR)
- •Left ventricular dysfunction (ejection fraction >20% and <50%)
- •New York Heart Association (NYHA) class II-IVa symptoms
- •Sign informed consent to participate in the study
排除标准
- •Left ventricular (LV) end-systolic dimension 70 mm
- •PA systolic pressure 70 mmHg (fixed)
- •Mitral valve (MV) orifice area <4.0 cm2
- •Commissural MR jet or leaflet anatomy not suitable for mTEER
- •Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
- •Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis
- •Complex congenital heart disease
- •Mechanical right heart valve (tricuspid or pulmonic)
- •Cardiac resynchronization therapy implanted within 3 months of enrollment
- •Hypersensitivity to aspirin and/or clopidogrel
- •History of medication non-adherence
研究组 & 干预措施
CardioMems
Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.
干预措施: CardioMEMS (Device)
Usual Care
Participants randomized to this arm will receive usual care involving GDMT.
结局指标
主要结局
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
时间窗: 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.
次要结局
- KCCQ score - Physical Function domain(Baseline, 1 month, 6 months, 12 months post-mTEER)
- All-cause mortality rate at 12 months(12 months)
- Rate of HFH at 12 months(12 months)
- Number of participants who achieve excellent clinical outcome(12 months)
- KCCQ score - Social Function domain(Baseline, 1 month, 6 months, 12 months post-mTEER)
- KCCQ score - Symptoms domain(Baseline, 1 month, 6 months, 12 months post-mTEER)
- KCCQ score - Quality of Life domain(Baseline, 1 month, 6 months, 12 months post-mTEER)
- Change in New York Heart Association (NYHA) Classification at 1-, 6-, and 12-months post-mTEER relative to baseline.(Baseline, 1 month, 6 months, 12 months)
- 6-minute walk test (6MWT) at 12 months(12 months)
- Change in 6-minute walk test (6MWT) from baseline to 12 months(Baseline and 12 months)
- Win ratio(Baseline and 12 months)
- Echocardiographic estimates of RV-PA coupling indices(12 months)
- Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)(12 months)
- Single-leaflet Device Detachments(12 months)
- Device Embolizations (MitraClip)(12 months)
- Endocarditis (Requiring Surgery)(12 months)
- Mitral Stenosis (Requiring Surgery)(12 months)
- Device- or System-related Failures(12 months)
- In Situ Pulmonary Thrombosis(12 months)
- Device Embolizations (CardioMEMS)(12 months)
研究者
Nir Uriel
Seymour, Paul, and Gloria Milstein Professor of Cardiology
Columbia University