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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

Ages 18 to 90 · All sexes

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

About the study

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.

What is being tested

• CardioMEMS (device)

Sponsor: Columbia University · Participants: 60 · Started: Dec 18, 2024

Contact the study team

• Kate Dalton, MS, RD, CCRC · Phone: (347) 514-3366

Official record on ClinicalTrials.gov — NCT06241430

Locations in the U.S.

Conditions

• Mitral Valve Insufficiency
• Heart Failure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.