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
Columbia University
Summary
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.
Description
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…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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…
Interventions
- DeviceCardioMEMS
Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.
Location
- Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew York, New York