The CardioClip Study

Columbia University

Status

Enrolling

Conditions

Mitral Regurgitation

Heart Failure With Reduced Ejection Fraction

Treatments

Device: CardioMEMS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06241430

AAAU9731

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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., >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