PARTNER 3 Trial - Aortic Valve-in-Valve

Not Applicable

Recruiting

• Conditions: Aortic Stenosis, Severe; Aortic Stenosis

• Registration Number: NCT03003299
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-28
• Study Start: 2017-01-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2033-01
• Study Completion: 2038-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke	1 year	Number of patients that died and/or had a stroke

Secondary Outcome Measures

Name	Time	Method
Peak gradient	30 days	Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
Kansas City Cardiomyopathy Questionnaire (KCCQ)	30 days	Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
Six-Minute Walk Test (6MWT)	30 days	Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Mean gradient	30 days	Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
New York Heart Association (NYHA) Classification	30 days	Change from baseline in NYHA. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.

Trial Locations

Locations (51)

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Sutter Medical Center; 🇺🇸 Sacramento, California, United States

Kaiser Permanente San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

UC Health Northern Colorado/Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

JFK Medical Center/ Atlantic Clinical Research Collaborative; 🇺🇸 Atlantis, Florida, United States

University of Florida, Gainesville; 🇺🇸 Gainesville, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Scroll for more (41 remaining)