The CardioClip Study for Heart Failure and Mitral Regurgitation
This study, called The CardioClip Study, is looking at a new way to help people with heart failure (when your heart can't pump enough blood) and mitral regurgitation (a leaky heart valve). It uses a wireless sensor called CardioMEMS CardioClip, which is placed in your pulmonary artery (a blood vessel in your lungs) using a non-surgical procedure similar to mTEER. The sensor constantly sends information about your heart's pressure, allowing doctors to adjust your medications in real-time. The goal is to see if this monitoring can improve your health and well-being. You might be able to join if you are 18-90 years old, have significant mitral regurgitation, and certain heart function levels. The study will measure changes in your quality of life 12 months after the mTEER procedure. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 60 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo the mTEER procedure to have the CardioMEMS CardioClip device inserted. Your quality of life will be assessed at 12 months after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life will be measured 12 months after the mTEER procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The CardioClip Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nir Uriel, MD · PRINCIPAL_INVESTIGATOR · Columbia University
- Michael Brener, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.