Tests a pressure sensor to guide heart failure care after valve repair
Tests a wireless pressure sensor in adults with heart failure and leaky mitral valves.
Plain-language title generated from the registry record
Registry title: The CardioClip Study
Key facts
- Where
- New York, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06241430, who can take part
Where in United States
- Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Columbia University
- Trial code
- NCT06241430
- Record updated
- 29 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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.