The CardioClip Study
Recruiting · NCT06241430 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital - New York, New York, United States