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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 90 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The CardioClip study tests a wireless sensor that tracks pressure in the artery carrying blood from the heart to the lungs. The sensor is placed through a vein in the groin, and its readings may help doctors adjust medicines. The study is for people with a badly leaking mitral heart valve and a weakened heart pump.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a moderate-to-severe or severe mitral valve leak caused by changes in the heart.
- Have a weakened main heart pump that pushes out more than 20% but less than 50% of its blood with each beat.
- Have heart failure symptoms rated NYHA class II–IVa, which range from symptoms during activity to symptoms at rest.
- Sign a form agreeing to join the study after learning about it.
Who can't join
- The listing gives limits of 70 mm for heart chamber size after pumping and 70 mmHg for fixed lung artery pressure. It does not say whether values must be above or below these limits.
- Have a mitral valve opening smaller than 4.0 square centimeters, or a valve shape or leak location that is not suited to a repair called mTEER.
- Are likely to need a heart transplant or an implanted heart pump within 12 months.
- Have had more than one blood clot in the lungs or deep veins.
- Have a complex heart problem present since birth, or a mechanical replacement valve on the right side of the heart.
- Had a device placed to help the heart chambers beat together within 3 months before joining.
- Have an allergy or strong reaction to aspirin or clopidogrel.
- Have a history of not taking medicines as directed.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NY
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital · New York, NY 10032Kate Dalton, MS, RD, CCRC · Study contact · keb2114@cumc.columbia.eduNir Uriel, MD · Principal investigatorMichael Brener, MD · Principal investigatorMore trials in New York