NCT06241430 · Columbia University
The CardioClip Study
(CardioClip)
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations