Clinical trial NCT05172973: ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Official title: Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Insufficiency
Aortic Valve Stenosis
Keywords: Transcatheter aortic valve replacement (TAVR)
Transcatheter aortic valve implantation (TAVI)
SAPIEN X4
Valve-in-valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 200
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 who are at high or greater risk with a failing aortic bioprosthetic valve.

Detailed description: Prospective, single arm, multicenter study

Eligibility criteria: Inclusion Criteria:

1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
2. Bioprosthetic valve size suitable for SAPIEN X4 THV
3. NYHA functional class ≥ II
4. Heart Team agrees the subject is at high or greater surgical risk
5. 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. Failing valve has moderate or severe paravalvular regurgitation
3. Failing valve is unstable, rocking, or not structurally intact
4. 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
5. Increased risk of THV embolization
6. Surgical or transcatheter valve in the mitral position
7. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
9. Left ventricular ejection fraction \< 20%
10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
11. Increased risk of coronary artery obstruction after THV implantation
12. Myocardial infarction within 30 days prior to the study procedure
13. Hypertrophic cardiomyopathy with subvalvular obstruction
14. Subjects with planned concomitant ablation for atrial fibrillation
15. Clinically significant coronary artery disease requiring revascularization
16. 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.
17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
18. Endocarditis within 180 days prior to the study procedure
19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
21. Renal insufficiency and/or renal replacement therapy
22. Leukopenia, anemia, thrombocytopenia
23. Inability to tolerate or condition precluding treatment with antithrombotic therapy
24. Hypercoagulable state or other condition that increases risk of thrombosis
25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
26. Subject refuses blood products
27. Body mass index \> 50 kg/m2
28. Estimated life expectancy \< 24 months
29. Female who is pregnant or lactating
30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
31. Participating in another investigational drug or device study that has not reached its primary endpoint
32. 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: Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: 30 days
measure: KCCQ score
timeFrame: 1 year
measure: New York Heart Association (NYHA) functional class
timeFrame: 30 days
measure: NYHA functional class
timeFrame: 1 year
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
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
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Loveland
country: United States
facility: UC Health Medical Center of the Rockies
state: Colorado
city: Naples
country: United States
facility: Naples Community Hospital Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Emory University Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Evanston
country: United States
facility: Northwestern University Chicago
state: Illinois
city: Lisle
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
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 Detroit
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health System Morristown
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Cornelll University New York
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / NYPH
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Health System
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health and 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: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
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: Seattle
country: United States
facility: University of Washington Seattle
state: Washington
city: Vancouver
country: Canada
facility: St. Paul's Hospital Vancouver
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
Study officials:
affiliation: Piedmont Atlanta Hospital
name: Pradeep Yadav, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Naples Community Hospital
name: Robert Cubbedu, MD
role: PRINCIPAL_INVESTIGATOR
References: