Monitoring heart function with a wireless sensor for heart failure patients
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
NA · Columbia University · NCT06241430
This study tests whether a wireless sensor can help doctors keep a closer eye on heart function in patients with heart failure and mitral regurgitation to improve their treatment and outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06241430 on ClinicalTrials.gov |
What this trial studies
The CardioClip study investigates the use of a wireless sensor to continuously monitor pulmonary artery pressure in patients with heart failure and mitral regurgitation. This sensor is implanted using a minimally invasive procedure similar to the mitral transcatheter edge-to-edge repair (mTEER). By providing real-time data on heart function, the study aims to enable healthcare providers to adjust treatments more effectively, potentially improving patient outcomes. The findings could inform future research on the benefits of wireless monitoring in managing valve disease and heart failure.
Who should consider this trial
Good fit: Ideal candidates include individuals with moderate to severe secondary mitral regurgitation and left ventricular dysfunction, experiencing NYHA class II-IVa symptoms.
Not a fit: Patients with severe left ventricular dilation, fixed pulmonary artery pressure, or those likely to undergo heart transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of heart failure, reducing hospitalizations and improving quality of life for patients.
How similar studies have performed: Other studies using similar wireless monitoring technologies have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Nir Uriel, MD — Columbia University
- Study coordinator: Kate Dalton, MS, RD, CCRC
- Email: keb2114@cumc.columbia.edu
- Phone: (347) 514-3366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation, Heart failure, Reduced ejection fraction, Mitral regurgitation, mTEER, CardioMems, Guideline-directed medical therapy