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

NCT02830204 | Completed Results DMC FDA Device

• 1 other identifier: 016-100
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Mitral Annular Calcification

Keywords

mitral valve regurgitation; mitral valve stenosis

Outcome Measures

Primary Outcomes (3)

• Procedural Success

  Procedural Success is defined as: 1. Device success, and 2. 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 (AKI) (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)

  30 days

• Technical Success

  Technical Success is defined as: 1. Alive, with 2. Successful access, delivery and retrieval of the device delivery system, and 3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and 4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

  Procedure Stop Time

• Device Success

  Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. 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 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. 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 3. 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)

  30 days

Secondary Outcomes (3)

• Device Success

  6 months

• Device Success

  1 year

• Subject Success

  1 year

Study Arms (1)

Mitral Valve Replacement (MVR) with Sapien3

EXPERIMENTAL

subjects with surgical MVR with Sapien3

Device: Mitral Valve Replacement (MVR) with Sapien3

Interventions

Mitral Valve Replacement (MVR) with Sapien3 DEVICE

subjects with surgical MVR with Sapien3

Also known as: MVR

Mitral Valve Replacement (MVR) with Sapien3

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baylor Research Institute: lead
• Edwards Lifesciences: collaborator

Study Sites (6)

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

MHRI Maryland

Baltimore, Maryland, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This study was limited by inadequate data capture and limited availability of full echo results.

Results Point of Contact

• Title: Walter Cerqueira
• Organization: Baylor Scott and White Research Institute

walter.cerqueira@bswhealth.org

469-814-3393

Study Officials

• Robert Smith, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Cardiothoracic Surgeon

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: July 12, 2016
• Study Start: November 4, 2016
• Primary Completion: January 3, 2023
• Study Completion: November 29, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)