ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
About this trial
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
Heart Team agrees the subject is at high or greater surgical risk
Disqualifiers
Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
Interatrial septum or left atrium not suitable for transcatheter transseptal access
Failing valve has mild or greater paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Trial design
Design model
Single group
Treatments tested in this trial
SAPIEN X4 THV
DeviceImplantation of the SAPIEN X4 valve
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: TMVR in failing mitral surgical bioprosthetic valveExperimental treatment 1 intervention
Group B: TMVR in failing native mitral valve with an annuloplasty ringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Non-hierarchical composite of death and stroke at 1 year
The number of patients that died or had a stroke
Time frame
1 yearSecondary outcomes
1
Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame
30 days2
Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame
1 year3
New York Heart Association (NYHA) functional class compared to baseline
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Time frame
30 days4
New York Heart Association (NYHA) functional class compared to baseline
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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