NCT06241430Recruiting
The CardioClip Study
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Jan 2024
- Start date
- 18 Dec 2024
- Primary completion date
- Jun 2030
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT06241430
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 18 Dec 2024 to the primary completion date, Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.