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

RECRUITING

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).

info
Simpliy with AI

Study details:

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

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
  • Subject considered to be part of a vulnerable population
  • info
    Simplify with AI

    Eligibility

    Age eligible for study : 0 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-06-20

    Primary completion: 2025-06-01

    Study completion finish: 2034-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05172960

    Intervention or treatment

    DEVICE: SAPIEN X4 THV

    Conditions

    • Aortic Stenosis, Severe

    Find a site

    Closest Location:

    Royal Adelaide Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Adelaide Hospital

      Adelaide, South Australia, Australia

    • St. Andrews War Memorial Hospital

      Spring Hill, Queensland, Australia

    • The Royal Melbourne Hospital

      Parkville, Not Specified, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: TAVR - Main Cohort
    • Subjects will undergo transcatheter aortic valve replacement (TAVR)
    DEVICE: SAPIEN X4 THV
    • Implantation of the SAPIEN X4 valve
    EXPERIMENTAL: TAVR - Bicuspid Registry
    • Subjects with bicuspid aortic valve morphology will undergo TAVR
    DEVICE: SAPIEN X4 THV
    • Implantation of the SAPIEN X4 valve

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Non-hierarchical composite of death and strokeThe number of patients that died or had a stroke1 year

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baselineThe number of patients that met all of these criteria. 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.1 year
    Paravalvular leakParavalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe30 days
    New permanent pacemaker implantationThe number of patients with this event30 days

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

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

    Other trails to consider

    Top searched conditions