The CardioClip Study

Launched by COLUMBIA UNIVERSITY · Jan 27, 2024

Keywords

ClinConnect Summary

The CardioClip study is looking into a new way to help people with heart failure and a specific heart valve problem called mitral regurgitation. Researchers are testing a small wireless sensor that can be placed in the body through a vein in the groin, similar to a procedure that doesn't require surgery. This sensor measures pressure in the pulmonary artery and sends continuous updates to doctors about how the heart is functioning. By having real-time information, doctors may be able to adjust medications more effectively, potentially improving outcomes for patients.

To participate in this study, you need to be between the ages of 65 and 74 and have moderate to severe issues with your heart's function, specifically related to the mitral valve. You should also have symptoms that make everyday activities harder. If you join the study, you can expect to have regular check-ups where the sensor's data will be monitored closely. This trial is important because it could lead to more research on how these sensors might help others with heart problems in the future.

Gender

ALL

Eligibility criteria

• 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