The CardioClip Study (NCT06241430) | Clinical Trial Compass
RecruitingNot Applicable
The CardioClip Study
United States60 participantsStarted 2024-12-18
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.