| NCT ID | NCT06241430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-18 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Nir Uriel, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06241430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06241430 currently recruiting?
Yes, NCT06241430 is actively recruiting participants. Contact the research team at keb2114@cumc.columbia.edu for enrollment information.
Where is the NCT06241430 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06241430 clinical trial?
NCT06241430 is sponsored by Columbia University. The principal investigator is Nir Uriel, MD at Columbia University. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.