NCT03003299 PARTNER 3 Trial - Aortic Valve-in-Valve
| NCT ID | NCT03003299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2017-01-05 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2017-01-05 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Chris S Malaisrie, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT03003299 clinical trial?
This trial is open to participants of all sexes, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03003299 currently recruiting?
Yes, NCT03003299 is actively recruiting participants. Contact the research team at THV_CT.gov@Edwards.com for enrollment information.
Where is the NCT03003299 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Sacramento, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT03003299 clinical trial?
NCT03003299 is sponsored by Edwards Lifesciences. The principal investigator is Chris S Malaisrie, MD at Northwestern University. The trial plans to enroll 125 participants.