NCT05172960RecruitingNot Applicable
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Edwards Lifesciences70 sites in 4 countries1,234 target enrollmentStarted: June 20, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,234
- Locations
- 70
- Primary Endpoint
- Non-hierarchical composite of death and stroke
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TAVR - Bicuspid Registry
Experimental
Subjects with bicuspid aortic valve morphology will undergo TAVR
Intervention: SAPIEN X4 THV (Device)
TAVR - Main Cohort
Experimental
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Intervention: SAPIEN X4 THV (Device)
TAVR - X4S Registry
Experimental
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Intervention: SAPIEN X4S (Device)
Outcomes
Primary Outcomes
Non-hierarchical composite of death and stroke
Time Frame: 1 year
The number of patients that died or had a stroke
Secondary Outcomes
- New permanent pacemaker implantation(30 days)
- 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(1 year)
- Paravalvular leak(30 days)
Investigators
Study Sites (70)
Loading locations...
Similar Trials
Recruiting
Not Applicable
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesAortic Valve StenosisAortic Valve InsufficiencyNCT05172973Edwards Lifesciences200
Not yet recruiting
Not Applicable
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - MitralMitral Valve DiseaseMitral RegurgitationMitral StenosisNCT06167213Edwards Lifesciences125
Completed
Not Applicable
Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular DiseasePeripheral Artery DiseaseNCT01658540Ettore Sansavini Health Science Foundation105
Completed
Not Applicable
Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial DiseasePeripheral Artery DiseaseAtherosclerosisNCT01834495Korea University Guro Hospital230
Completed
Not Applicable
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese PopulationSymptomatic Aortic StenosisAortic RegurgitationAortic StenosisNCT03314857Edwards Lifesciences67