ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

  • STATUS
    Recruiting
  • End date
    Dec 14, 2034
  • participants needed
    915
  • sponsor
    Edwards Lifesciences
Updated on 7 October 2022

Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Description

This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.

Details
Condition Aortic Stenosis, Severe
Treatment SAPIEN X4 THV
Clinical Study IdentifierNCT05172960
SponsorEdwards Lifesciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Severe, calcific AS
Native aortic annulus size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
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
Aortic valve is unicuspid, bicuspid or non-calcified
Pre-existing mechanical or bioprosthetic valve in any position
Severe aortic regurgitation (> 3+)
Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
Left ventricular ejection fraction < 20%
Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
Increased risk of coronary artery obstruction after THV implantation
Myocardial infarction within 30 days prior to the study procedure
Hypertrophic cardiomyopathy with subvalvular obstruction
Subjects with planned concomitant ablation for atrial fibrillation
Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). 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 (unless part of planned strategy for treatment of CAD)
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
BMI > 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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