Clinical trial NCT05526560: Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Official title: A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Stenosis
Mitral Valve Insufficiency
Keywords: Mitral Valve Replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring replacement of their native or prosthetic mitral valve

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.

Detailed description: MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Freedom from valve related death or valve related reintervention
timeFrame: 1 year
measure: Hemodynamic performance as measured by peak and mean gradient by echocardiography
timeFrame: 1 year
Secondary outcomes:
measure: Early rates of major cardiac events
timeFrame: 0 to 30 days
measure: Late linearized rates of major cardiac events
timeFrame: >30 days and up through 10 years post implant
measure: Functional improvement from baseline for New York Heart Association (NYHA) Class
timeFrame: Annually up to 10 years post implant
measure: Improvement from baseline for Quality of Life
timeFrame: 1, 3, 5, 8, and 10 years post implant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Athens
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Carmel
country: United States
facility: Ascension St. Vincent Heart Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Barnes-Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
city: Nashville
country: United States
facility: Tristar Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Ascension Saint Thomas
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Eau Claire
country: United States
facility: Mayo Clinic Health System - Eau Claire
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital and Vancouver General Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital (LHSC)
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bad Neustadt
country: Germany
facility: Rhoen-Klinikum Campus Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bonn
country: Germany
facility: University Clinic Bonn
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Cleveland Clinic London
Study officials:
affiliation: University of Michigan
name: Gorav Ailawadi, MD
role: PRINCIPAL_INVESTIGATOR
References: