VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study (NCT00512005) | Clinical Trial Compass
UnknownPhase 1
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
United States30 participantsStarted 2008-01
Plain-language summary
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.
Who can participate
Age range
18 Years – 85 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.
Key Inclusion Criteria:
* Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
* NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%
Key Exclusion Criteria:
* History of pericarditis.
* Creatinine \> 2.2 at the time of the procedure
* INR \> 1.8 at the time of the procedure
* Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
* Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
* Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
* Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
* Structural abnormality of the mitral valve
* Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
* Pericardial effusion \>5 mm via echocardiography.
* Posterior wall end-diastolic dimension \>1.3 cm.
* Left ventricular end diastolic diameter \> 7.0 cm.
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
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System