Clinical trial NCT03003299: PARTNER 3 Trial - Aortic Valve-in-Valve
Official title: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Aortic Stenosis, Severe
Keywords: SAPIEN 3
PARTNER 3
cardiovascular disease
heart disease
aortic stenosis
SAVR
TAVR
failing surgical valve
failing bioprosthetic valve
failing valve
SAPIEN 3 Ultra
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Detailed description: This is a prospective, single-arm, multicenter study.

Eligibility criteria: Inclusion Criteria:

1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team agrees the patient is low to intermediate risk.
5. Heart Team agrees valve implantation will likely benefit the patient.
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
2. Severe regurgitation (\> 3+) or stenosis of any other valve
3. Failing valve has moderate or severe paravalvular regurgitation
4. Failing valve is unstable, rocking, or not structurally intact
5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
6. Increased risk of embolization of THV
7. Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
10. Anatomical characteristics that would preclude safe access to the apex (Transapical)
11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment
12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
15. Untreated clinically significant coronary artery disease requiring revascularization
16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
17. Emergency interventional/surgical procedures within 30 days prior to the procedure
18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
19. Hypertrophic cardiomyopathy with obstruction
20. LVEF \< 30%
21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
24. Stroke or transient ischemic attack within 90 days of enrollment
25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
26. Renal insufficiency and/or renal replacement therapy at the time of screening
27. Active bacterial endocarditis within 180 days of the procedure
28. Patient refuses blood products
29. Estimated life expectancy \< 24 months
30. Positive urine or serum pregnancy test in female subjects of childbearing potential
31. Currently participating in an investigational drug or another device study

Primary outcomes:
measure: Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
timeFrame: 1 year
Secondary outcomes:
measure: Mean gradient
timeFrame: 30 days
measure: Peak gradient
timeFrame: 30 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days
measure: New York Heart Association (NYHA) Classification
timeFrame: 30 days
measure: Six-Minute Walk Test (6MWT)
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
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: Atlantis
country: United States
facility: JFK Medical Center/ Atlantic Clinical Research Collaborative
state: Florida
city: Gainesville
country: United States
facility: University of Florida, Gainesville
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
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: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City Mid America
state: Missouri
city: Saint Louis
country: United States
facility: Washington University/ Barnes-Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Newark
country: United States
facility: Newark Beth Israel
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: New York University (NYU) Langone Medical Center
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Carolina's Health System
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular (Rex Hospital)
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
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Health Services
state: Tennessee
city: Austin
country: United States
facility: Austin Heart, PLLC
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Inova Heart and vascular Instritute (Fairfax Inova)
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Chris S Malaisrie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Alan Zajarias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mayra Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
References: