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:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01931956
Eligibility Criteria:
Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm.
Key Inclusion Criteria:
* The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
* Male or non-pregnant female
* Trans-septal catheterization is determined to be feasible by the treating physician
High Risk Arm:
* Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:
1. Porcelain aorta or mobile ascending aortic atheroma
2. Post-radiation mediastinum
3. Previous mediastinitis
4. Functional MR with EF \<40
5. Over 75 years old with EF\<40
6. Re-operation with patent grafts
7. Two or more prior chest surgeries
8. Hepatic cirrhosis
9. Three or more of the following STS high risk factors 9.1 Creatinine \>2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF\<35
* Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
* American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower
Non-High Risk Arm:
* Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:
1\. Symptomatic with \>25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) \>50 mmHg at rest or \>60 mmHg with exercise
* Candidate for MV repair or replacement surgery, including cardiopulmonary bypass
Key Exclusion Criteria:
* Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
* In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
* MV orifice area \<4.0 cm2
* If leaflet flail is present:
1. Flail Width ≥15 mm, or
2. Flail Gap ≥10 mm.
* If leaflet tethering is present:
1\. Vertical coaptation length \<2 mm
* Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
2. Presence of a significant cleft of A2 or P2 scallops
3. More than one anatomic criteria dimensionally near the exclusion limits
4. Bileaflet flail or severe bileaflet prolapse
5. Lack of both primary and secondary chordal support
* Hemodynamic instability (systolic pressure \<90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
* Need for emergency surgery for any reason
* Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
* History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
* Life expectancy \<12 months
* Active infections requiring current antibiotic therapy
* Patients in whom transesophageal echocardiography (TEE) is contraindicated
High Risk Arm:
* EF \<20%, and/or LVESD \>60 mm
Non-High Risk Arm:
* The need for any other cardiac surgery
* Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
* Severe Left Ventricular (LV) dysfunction (EF \<25% and/or LVESD \>55mm)
* Severe mitral annular calcification
* Systolic anterior motion of the MV leaflet
* Hypertrophic cardiomyopathy
* History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
* Upper GI bleeding within the prior 6 months
* Platelet count \<75,000 cells/mm³
* Creatinine \>2.5mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01931956
Study Brief:
Protocol Section:
NCT01931956