Overview

Condition mitral annular calcification
Treatment mitral valve replacement with sapien3
Phase phase 1/phase 2
Sponsor Baylor Research Institute
Start date April 2016
End date December 2018
Trial size 30 participants
Trial identifier NCT02830204, 016-100

Summary

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.

Recruiting in the following locations…

United States Texas
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
subjects with surgical MVR with Sapien3
mitral valve replacement with sapien3 MVR
subjects with surgical MVR with Sapien3

Primary Outcomes

Measure
Procedural success
time frame: 30 days
Technical success
time frame: Procedure Stop Time
Device success
time frame: 30 days

Secondary Outcomes

Measure
Device success
time frame: 6 months
Device Success
time frame: 1 year
Subject success
time frame: 1 year

Eligibility Criteria

Male or female participants at least 22 years old.

Inclusion Criteria: - 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, TVP, and atrial fibrillation (AF) ablation. - 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 Exclusion Criteria: - 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 CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)]. - Untreated coronary artery disease in need of revascularization - 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. - An estimated Glomerular Filtration Rate (eGFR) <30 as calculated using the Modification of Diet in Renal Disease (MDRD) formula or 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

Additional Information

Official title Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Principal investigator Robert Smith, MD
Description Technical Success: Alive, with - Successful access, delivery and retrieval of the device delivery system, and - Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and - No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure Device Success: Alive and stroke free, with - Original intended device in place, and - No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/Operating Room(OR)), and - Intended performance of the device: - Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = Mitral Valve Area (MVA) < 1.5cm2 and Mitral Valve (MV) gradient > 5mmHg, Insufficiency = Mitral Regurgitation (MR) >1+), and - Absence of para-device complications (e.g., Paravalvular Leak (PVL) > mild, need for a Permanent Pacemaker (PPM), erosion, Annular rupture or Aortic Valve (AV) Groove disruption, Left Ventricular Outflow Tract (LVOT) gradient increase > 10mmHg) Procedural Success: Device success, and - No device or procedure related Serious Adverse Events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 Acute Kidney Injury (includes new dialysis); Myocardial Infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours) 6.2 Secondary objective(s) Device Success (at 6 months and 1 year) - Subject success 1 year Device Success: Alive and stroke free, with - Original intended device in place, and - No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/Operating Room (OR)), and - Intended performance of the device: - Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and - Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Baylor Research Institute.