ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

NCT06167213 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2021-05-Mitral
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mitral Regurgitation; Mitral Valve Disease; Mitral Stenosis

Keywords

SAPIEN X4; Valve-in-Valve; Valve-in-Ring

Outcome Measures

Primary Outcomes (1)

• Non-hierarchical composite of death and stroke at 1 year

  The number of patients that died or had a stroke

  1 year

Secondary Outcomes (4)

• Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline

  30 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline

  1 year

• New York Heart Association (NYHA) functional class compared to baseline

  30 days

• New York Heart Association (NYHA) functional class compared to baseline

  1 year

Study Arms (2)

TMVR in failing mitral surgical bioprosthetic valve

EXPERIMENTAL

Transcatheter Mitral Valve Replacement (TMVR) in subjects with a failing mitral surgical bioprosthetic valve.

Device: SAPIEN X4 THV

TMVR in failing native mitral valve with an annuloplasty ring

EXPERIMENTAL

Transcatheter Mitral Valve Replacement (TMVR) in subjects with a failing native mitral valve with an annuloplasty ring.

Device: SAPIEN X4 THV

Interventions

SAPIEN X4 THV DEVICE

Implantation of the SAPIEN X4 valve

TMVR in failing mitral surgical bioprosthetic valve; TMVR in failing native mitral valve with an annuloplasty ring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

You may not qualify if:

• 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
• Annuloplasty ring dehiscence
• Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 10 mmHg at the end of the index procedure for implantation of the original valve
• Annuloplasty ring type not favorable for THV implantation
• Increased risk of THV embolization
• Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
• Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
• Severe right ventricle (RV) dysfunction
• Severe regurgitation or stenosis of any other valve
• Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
• Left ventricular ejection fraction \< 20%
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

Sponsors & Collaborators

• Edwards Lifesciences: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Amar Krishnaswamy, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• James McCabe, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwards THV Clinical Affairs

CONTACT

949-250-2500; THV_CT.gov@edwards.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2038
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share