Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00512005
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00512005
Study Brief:
Protocol Section:
NCT00512005