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

Official title

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

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 with symptomatic, severe, calcific aortic stenosis (AS).

Detailed description

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

Interventions

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

Primary outcome measures

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

Secondary outcome measures (3)

• 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 baseline [Time frame: 1 year]
• Paravalvular leak [Time frame: 30 days]
• New permanent pacemaker implantation [Time frame: 30 days]

Eligibility criteria

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

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 · 58 centers

• Scripps Memorial Hospital La Jolla — La Jolla
• Kaiser Los Angeles — Los Angeles
• Cedars-Sinai Medical Center — Los Angeles
• Hoag Memorial Hospital Presbyterian — Newport Beach
• UC Davis Medical Center Sacramento — Sacramento
• Bay Area Structural Heart at Sutter Health — San Francisco
• Kaiser San Francisco Medical Center — San Francisco
• Stanford University — Stanford
• … and 50 more centers

Australia · 3 centers

• St. Andrews War Memorial Hospital — Spring Hill
• Royal Adelaide Hospital — Adelaide
• The Royal Melbourne Hospital — Parkville

Canada · 3 centers

• St. Paul's Hospital System — Vancouver
• Hamilton Health Services — Hamilton
• Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval — Québec

New Zealand · 1 center

• Christchurch Hospital — Christchurch

Identifiers

NCT: NCT05172960 · 2021-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗