Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

Completed · Not applicable

Conditions studied: Mitral Annular Calcification

In brief

The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.

Key facts

Study ID

NCT02830204

Run by

Baylor Research Institute

People needed

25

Starts

2016-11-04

Expected to finish

2023-11-29

Last updated by the study team

2025-02-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure.
• Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater.
• The subject is at least 22 years old.
• The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: Maze, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy.
• The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• The study subject agrees to comply with all required post-procedure follow-up visits

You may not qualify if…

• Evidence of an acute myocardial infarction (MI) ≤ 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation of creatine kinase-myocardial band (CK-MB) ≥ twice normal in the presence of myocardial band (MB) elevation and/or troponin level elevation (WHO definition)].
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
• Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL).
• Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure.
• Need for emergency surgery for any reason.
• Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30%.
• Severe right ventricular dysfunction
• Pregnancy, lactation, or planning to become pregnant
• Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis.
• Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment.
• A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be maintained on oral anticoagulant following the study procedure.
• End stage renal disease requiring dialysis
• Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 30 days of the procedure.
• Estimated life expectancy < 12 months

Where it is running

• St. Vincent Heart Center — Indianapolis, Indiana, United States
• MHRI Maryland — Baltimore, Maryland, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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