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Clinical Trials in the USA / NCT03003299
Recruiting Not applicable

PARTNER 3 Trial - Aortic Valve-in-Valve

NCT03003299 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2017-01-05
Last updated
2024-05-10

Condition(s) studied

Aortic StenosisAortic Stenosis, Severe

Investigational drug(s) / intervention(s)

Edwards SAPIEN 3/SAPIEN 3 Ultra THV

Edwards SAPIEN 3/SAPIEN 3 Ultra THV: Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona Recruiting
University of California Los Angeles Los Angeles California Recruiting
Sutter Medical Center Sacramento California Recruiting
Kaiser Permanente San Francisco San Francisco California Withdrawn
Stanford University Medical Center Stanford California Recruiting
UC Health Northern Colorado/Medical Center of the Rockies Loveland Colorado Recruiting
Hartford Hospital Hartford Connecticut Recruiting
JFK Medical Center/ Atlantic Clinical Research Collaborative Atlantis Florida Withdrawn
University of Florida, Gainesville Gainesville Florida Withdrawn
Emory University Hospital Atlanta Georgia Recruiting
Northwestern University Hospital Chicago Illinois Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Northshore University HealthSystem Evanston Illinois Withdrawn
Prairie Education and Research Cooperative Springfield Illinois Withdrawn
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
William Beaumont Hospital Royal Oak Michigan Withdrawn
University of Minnesota Medical Center Minneapolis Minnesota Withdrawn
Mayo Clinic Rochester Minnesota Recruiting
Saint Luke's Hospital of Kansas City Mid America Kansas City Missouri Withdrawn
Washington University/ Barnes-Jewish Hospital St Louis Missouri Recruiting
Nebraska Heart Institute Lincoln Nebraska Withdrawn
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Withdrawn
Newark Beth Israel Newark New Jersey Recruiting
University of Buffalo Buffalo New York Withdrawn
Winthrop University Hospital Mineola New York Recruiting
New York University (NYU) Langone Medical Center New York New York Withdrawn
Cornell University New York New York Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital New York New York Recruiting
Carolina's Health System Charlotte North Carolina Withdrawn
NC Heart and Vascular (Rex Hospital) Raleigh North Carolina Withdrawn
The Christ Hospital Cincinnati Ohio Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Recruiting
Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma Withdrawn
Providence Heart & Vascular Institute Portland Oregon Recruiting
University of Pennsylvania Hospital Philadelphia Pennsylvania Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
Lankenau Medical Center Wynnewood Pennsylvania Recruiting
Baptist Memorial Hospital Memphis Tennessee Withdrawn

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03003299 on ClinicalTrials.gov ↗ ← All trials in the USA