RecruitingNot ApplicableNCT06241430

The CardioClip Study

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


Sponsor

Columbia University

Enrollment

60 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive heart procedure called transcatheter edge-to-edge repair (mTEER) for people with heart failure caused by a leaky mitral valve (secondary mitral regurgitation). Instead of open-heart surgery, a small clip is used to repair the valve through a catheter — a much less invasive approach. **You may be eligible if...** - You have moderate-severe (3+) or severe (4+) mitral valve leakage caused by heart failure - Your heart's pumping function is reduced (ejection fraction between 20% and 50%) - You have symptoms of heart failure (NYHA class II–IVa) - Your mitral valve anatomy is suitable for the clip procedure **You may NOT be eligible if...** - Your left ventricle is severely enlarged (end-systolic dimension over 70 mm) - Your pulmonary artery pressure is severely elevated and fixed - Your mitral valve opening area is too small (less than 4.0 cm²) - You are likely to need a heart transplant or mechanical heart support device within 12 months - You have a history of recurrent blood clots - You have complex congenital heart disease - You have a mechanical heart valve on the right side - You have a history of not taking medications as prescribed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardioMEMS

Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.


Locations(1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

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NCT06241430


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