Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

NCT05526560 | Active Not Recruiting FDA Device

• 1 other identifier: 2022-09
• Study Type: observational
• Target: 504
• Locations: 4 countries
• Sites: 34

Brief Summary

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Conditions

Mitral Stenosis; Mitral Valve Insufficiency

Keywords

Mitral Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Freedom from valve related death or valve related reintervention

  Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee

  1 year

• Hemodynamic performance as measured by peak and mean gradient by echocardiography

  Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation

  1 year

Secondary Outcomes (4)

• Early rates of major cardiac events

  0 to 30 days

• Late linearized rates of major cardiac events

  >30 days and up through 10 years post implant

• Functional improvement from baseline for New York Heart Association (NYHA) Class

  Annually up to 10 years post implant

• Improvement from baseline for Quality of Life

  1, 3, 5, 8, and 10 years post implant

Study Arms (1)

Patients requiring replacement of their native or prosthetic mitral valve

Patients requiring replacement of their native or prosthetic mitral valve

Device: MITRIS RESILIA Mitral Valve, Model 11400M

Interventions

MITRIS RESILIA Mitral Valve, Model 11400M DEVICE

Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Patients requiring replacement of their native or prosthetic mitral valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring replacement of their native or prosthetic mitral valve

You may qualify if:

• years or older at the time of informed consent
• Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
• Provides written informed consent
• Willingness to follow protocol requirements

You may not qualify if:

• Active endocarditis 3 months prior to the procedure
• Stage 4 renal disease or requiring dialysis
• Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
• High predicted risk of mortality prior to procedure
• Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \> 8 or
• Surgeon estimated risk of mortality of \> 8

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (34)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Piedmont Heart Institute

Athens, Georgia, 30606, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Ascension St. Vincent Heart Center

Carmel, Indiana, 46290, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

St. Paul's Hospital and Vancouver General Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

London Health Sciences Centre, University Hospital (LHSC)

London, Ontario, N6G 5G1, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, QC G1V 4G5, Canada

Location

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Rhoen-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

University Clinic Bonn

Bonn, 53127, Germany

Location

Klinikum Links der Weser

Bremen, 28277, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Royal Papworth Hospital

Cambridge, SE5 9RS, United Kingdom

Location

St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Cleveland Clinic London

London, SW1X 7HY, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve Stenosis; Mitral Valve Insufficiency

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Gorav Ailawadi, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 2, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2035
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); DE (6); GB (4); US (20)