Not yet recruiting NCT06167213

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

No phase Interventional Mitral Regurgitation Mitral Valve Disease Mitral Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: SAPIEN X4 THV.
Who it may be relevant to: Registry conditions: Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral

Overview

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.

Detailed description

This is a prospective, single arm, multicenter, pivotal study.

Interventions

Device SAPIEN X4 THV
Implantation of the SAPIEN X4 valve

Primary outcome measures

Non-hierarchical composite of death and stroke at 1 year [Time frame: 1 year]

Secondary outcome measures (4)

Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [Time frame: 30 days]
Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [Time frame: 1 year]
New York Heart Association (NYHA) functional class compared to baseline [Time frame: 30 days]
New York Heart Association (NYHA) functional class compared to baseline [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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
Myocardial infarction within 30 days prior to the study procedure
Hypertrophic cardiomyopathy with subvalvular obstruction
Subjects with planned concomitant ablation for atrial fibrillation
Clinically significant coronary artery disease requiring revascularization
Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
Endocarditis within 180 days prior to the study procedure
Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
Renal insufficiency and/or renal replacement therapy
Leukopenia, anemia, thrombocytopenia
Inability to tolerate or condition precluding treatment with antithrombotic therapy
Hypercoagulable state or other condition that increases risk of thrombosis
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
Subject refuses blood products
Body mass index > 50 kg/m2
Estimated life expectancy < 24 months
Female who is pregnant or lactating
Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
Participating in another investigational drug or device study that has not reached its primary endpoint
Subject considered to be part of a vulnerable population

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06167213 · 2021-05-Mitral

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗