A prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve - Europe (MOMENTIS)

A prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve - Europe (MOMENTIS) - MOMENTIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033584

Enrollment

150

Registered

2024-05-10

Start date

2024-06-16

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I34.0 I05.8 I05.2

Interventions

Group 1: Arm 1: Adult subjects (18 years or older) diagnosed with Mitral valve disease which will be treated by a surgical valve replacement. Follow ups are taking place at discharge from Hospital ind

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18 years or older at the time of informed consent 2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery 3. Provides written informed consent 4. Willingness to follow protocol requirements

Exclusion criteria

Exclusion criteria: 1. Active endocarditis 3 months prior to the procedure 2. Stage 4 renal disease or requiring dialysis* 3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease 4. High predicted risk of mortality prior to procedure • STS PROM > 8 or • Surgeon estimated risk of mortality of > 8 *eGFR < 30 is excluded

Design outcomes

Primary

Measure	Time frame
• Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC • Hemodynamic performance at 1 year as confirmed by echocardiography and ECL evaluation which will include the following parameters: - Mean Gradient - Peak gradient - Transvalvular regurgitation and paravalvular leak, separately	—

Secondary

Measure	Time frame
• Linearized rates of major cardiac events summarizing early (= 30 days) and late (> 30 days) post-operative period inclusive of the follow events as determined by the CEC or ECL - Thromboembolism (Stroke, TIA, Non-Cerebral) - Valve thrombosis - Paravalvular leak (> mild ‘2+’) - Major bleeding - Nonstructural valve dysfunction (NSVD) - Structural valve deterioration (SVD) - Endocarditis - Valve related reintervention - Death • Functional improvement from baseline for NYHA Class (all follow-up time points) • Improvement from baseline for quality of life as measured by SF-36v2 (all applicable follow-up time points)	—

Measure

Time frame

• Linearized rates of major cardiac events summarizing early (= 30 days) and late (> 30 days) post-operative period inclusive of the follow events as determined by the CEC or ECL - Thromboembolism (Stroke, TIA, Non-Cerebral) - Valve thrombosis - Paravalvular leak (> mild ‘2+’) - Major bleeding - Nonstructural valve dysfunction (NSVD) - Structural valve deterioration (SVD) - Endocarditis - Valve related reintervention - Death • Functional improvement from baseline for NYHA Class (all follow-up time points) • Improvement from baseline for quality of life as measured by SF-36v2 (all applicable follow-up time points)

—

Countries

Germany, United Kingdom

Contacts

Public ContactSabrina Hundt

Edwards Lifesciences GmbH

sabrina_hundt@edwards.com+49 89 954750

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026