Actively Recruiting
The CardioClip Study
Led by Columbia University · Updated on 2025-06-25
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The CardioClip Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Significant (moderate-severe [3+] or severe [4+]) secondary mitral regurgitation
- Left ventricular dysfunction with ejection fraction greater than 20% and less than 50%
- New York Heart Association (NYHA) class II-IVa symptoms
- Signed informed consent to participate in the study
You will not qualify if you...
- Left ventricular end-systolic dimension of 70 mm or more
- Pulmonary artery systolic pressure of 70 mmHg or more (fixed)
- Mitral valve orifice area less than 4.0 cm2
- Commissural mitral regurgitation jet or leaflet anatomy unsuitable for mTEER
- Likely to undergo heart transplantation or left ventricular assist device implantation in the next 12 months
- Recurrent (more than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
K
Kate Dalton, MS, RD, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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