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Recruiting NCT05172973

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

No phase Interventional Aortic Valve Insufficiency Aortic Valve 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/X4S THV.
Who it may be relevant to
Registry conditions: Aortic Valve Insufficiency, Aortic Valve 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
United States, Canada
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 in Failing Aortic Bioprosthetic Valves

Overview

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Detailed description

Prospective, single arm, multicenter study

Interventions

  • Device SAPIEN X4/X4S THV
    Implantation of the SAPIEN X4/X4S valve

Primary outcome measures

  • Non-hierarchical composite of death and stroke [Time frame: 1 year]
Secondary outcome measures (4)
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) score [Time frame: 30 days]
  • KCCQ score [Time frame: 1 year]
  • New York Heart Association (NYHA) functional class [Time frame: 30 days]
  • NYHA functional class [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  • Bioprosthetic valve 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
  • Failing valve has moderate or severe paravalvular regurgitation
  • Failing valve is unstable, rocking, or not structurally intact
  • Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
  • Increased risk of THV embolization
  • Surgical or transcatheter valve in the mitral position
  • 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
  • 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
  • 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 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

United States · 33 centers
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Bay Area Structural Heart at Sutter Health — San Francisco
  • Kaiser San Francisco — San Francisco
  • Stanford University Medical Center — Stanford
  • UC Health Medical Center of the Rockies — Loveland
  • Naples Community Hospital Healthcare System — Naples
  • Emory University Atlanta — Atlanta
  • Piedmont Heart Institute — Atlanta
  • … and 25 more centers
Canada · 3 centers
  • St. Paul's Hospital Vancouver — Vancouver
  • Hamilton Health Sciences — Hamilton
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval — Québec

Identifiers

NCT: NCT05172973 · 2021-05-AVIV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗