EVEREST II Pivotal Study High Risk Registry (HRR)

Completed · Not applicable

Conditions studied: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency

In brief

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).

Key facts

Study ID

NCT01940120

Run by

Abbott Medical Devices

People needed

78

Starts

2007-02-01

Expected to finish

2013-02-01

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates for the high risk arm of the study must meet all of the following inclusion criteria:
• Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications:
• Porcelain aorta or mobile ascending aortic atheroma
• Post-radiation mediastinum
• Previous mediastinitis
• Functional MR with EF<40
• Over 75 years old with EF<40
• Re-operation with patent grafts
• Two or more prior chest surgeries
• Hepatic cirrhosis i Three or more of the following STS high risk factors: i) Creatinine > 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF<35
• Age 18 years or older.
• Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the EVEREST II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.
• The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.
• Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
• The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
• Transseptal catheterization is determined to be feasible by the treating physician.

You may not qualify if…

• Candidates will be excluded from the study if any of the following conditions are present:
• Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal).
• In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
• Ejection fraction < 20%, and/or end-systolic dimension > 60 mm as defined in Appendix A of the EVEREST II protocol.
• Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.
• If leaflet flail is present:
• Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or
• Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A.
• If leaflet tethering is present:
• a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A.
• Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
• Evidence of calcification in the grasping area of the A2 and/or P2 scallops
• Presence of a significant cleft of A2 or P2 scallops
• More than one anatomic criteria dimensionally near the exclusion limits
• Bileaflet flail or severe bileaflet prolapse
• Lack of both primary and secondary chordal support
• Hemodynamic instability defined as systolic pressure < 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.
• Need for emergent or urgent surgery for any reason.
• Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e. noncompliant, perforated).
• History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
• Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
• Intravenous drug abuse or suspected inability to adhere to follow-up.
• Patients in whom transesophageal echocardiography (TEE) is contraindicated.

Where it is running

• Evanston Northwestern Healthcare 2650 Ridge Ave., Walgreen Bldg, 3rd Floor, Cardiology — Evanston, Illinois, United States
• The Care Group Heart Center 10590 N. Meridian, Ste. 300 — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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