Clinical trial NCT05172960: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis, Severe
Keywords: Transcatheter aortic valve replacement (TAVR)
Transcatheter aortic valve implantation (TAVI)
SAPIEN X4
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 915
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

1. Severe, calcific AS
2. Native aortic annulus size suitable for SAPIEN X4 THV
3. NYHA functional class ≥ II
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
2. Aortic valve is unicuspid, bicuspid or non-calcified
3. Pre-existing mechanical or bioprosthetic valve in any position
4. Severe aortic regurgitation (\> 3+)
5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
7. Left ventricular ejection fraction \< 20%
8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
10. Increased risk of coronary artery obstruction after THV implantation
11. Myocardial infarction within 30 days prior to the study procedure
12. Hypertrophic cardiomyopathy with subvalvular obstruction
13. Subjects with planned concomitant ablation for atrial fibrillation
14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
15. 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.
16. 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)
17. Endocarditis within 180 days prior to the study procedure
18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
20. Renal insufficiency and/or renal replacement therapy
21. Leukopenia, anemia, thrombocytopenia
22. Inability to tolerate or condition precluding treatment with antithrombotic therapy
23. Hypercoagulable state or other condition that increases risk of thrombosis
24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
25. Subject refuses blood products
26. BMI \> 50 kg/m2
27. Estimated life expectancy \< 24 months
28. Female who is pregnant or lactating
29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
30. Participating in another investigational drug or device study that has not reached its primary endpoint
31. Subject considered to be part of a vulnerable population

Primary outcomes:
measure: Non-hierarchical composite of death and stroke
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Paravalvular leak
timeFrame: 30 days
measure: New permanent pacemaker implantation
timeFrame: 30 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Los Angeles
country: United States
facility: Kaiser Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center Sacramento
state: California
city: San Francisco
country: United States
facility: Bay Area Structural Heart at Sutter Health
state: California
city: San Francisco
country: United States
facility: Kaiser San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Loveland
country: United States
facility: UC Health Northern Colorado (Medical Center of the Rockies)
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: North Naples
country: United States
facility: Naples Community Hospital Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center Chicago
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem Research Institute Evanston
state: Illinois
city: Evanston
country: United States
facility: Northwestern University Chicago
state: Illinois
city: New Lenox
country: United States
facility: Silver Cross Hospital
state: Illinois
city: Carmel
country: United States
facility: St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University - Barnes-Jewish Hospital Saint Louis
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Hanover
state: New Hampshire
city: Morristown
country: United States
facility: Atlantic Health System Morristown
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo - Kaleida Health
state: New York
city: New York
country: United States
facility: Cornell Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Health System
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health and Heart Vascular Institute
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group Oklahoma City
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Clackamas
country: United States
facility: Kaiser Portland
state: Oregon
city: Portland
country: United States
facility: Providence Heart & Vascular Institute Portland
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health Harrisburg
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: Methodist Le Bonheur Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: HCA Houston Healthcare Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Memorial Hermann
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle
state: Washington
city: Spring Hill
country: Australia
facility: St. Andrews War Memorial Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
city: Vancouver
country: Canada
facility: St. Paul's Hospital System
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Services
state: Ontario
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval
state: Quebec
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Columbia University
name: Tamim M. Nazif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Rahul P. Sharma, MBBS
role: PRINCIPAL_INVESTIGATOR
References: