The CardioClip Study

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.

• All-cause mortality rate at 12 months [Срок оценки: 12 months]
• Rate of HFH at 12 months [Срок оценки: 12 months]
• Number of participants who achieve excellent clinical outcome [Срок оценки: 12 months]
• KCCQ score - Physical Function domain [Срок оценки: Baseline, 1 month, 6 months, 12 months post-mTEER]
• KCCQ score - Social Function domain [Срок оценки: Baseline, 1 month, 6 months, 12 months post-mTEER]
• KCCQ score - Symptoms domain [Срок оценки: Baseline, 1 month, 6 months, 12 months post-mTEER]
• KCCQ score - Quality of Life domain [Срок оценки: 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. [Срок оценки: Baseline, 1 month, 6 months, 12 months]
• 6-minute walk test (6MWT) at 12 months [Срок оценки: 12 months]
• Change in 6-minute walk test (6MWT) from baseline to 12 months [Срок оценки: Baseline and 12 months]
• Win ratio [Срок оценки: Baseline and 12 months]
• Echocardiographic estimates of RV-PA coupling indices [Срок оценки: 12 months]