PARTNER 3 Trial - Aortic Valve-in-Valve

Aortic Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03003299
• Other study ID #: 2015-08 AVIV
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: April 2038

Study information

• Verified date: May 2023
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: (949) 250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, single-arm, multicenter study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 2038
• Est. primary completion date: January 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia
United States	Emory University Hospital	Atlanta	Georgia
United States	JFK Medical Center/ Atlantic Clinical Research Collaborative	Atlantis	Florida
United States	Austin Heart, PLLC	Austin	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Carolina's Health System	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	The Heart Hospital Baylor Plano	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Northshore University HealthSystem	Evanston	Illinois
United States	Inova Heart and vascular Instritute (Fairfax Inova)	Fairfax	Virginia
United States	University of Florida, Gainesville	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Saint Luke's Hospital of Kansas City Mid America	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	University of California Los Angeles	Los Angeles	California
United States	UC Health Northern Colorado/Medical Center of the Rockies	Loveland	Colorado
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Winthrop University Hospital	Mineola	New York
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Saint Thomas Health Services	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center/ New York Presbyterian Hospital	New York	New York
United States	Cornell University	New York	New York
United States	New York University (NYU) Langone Medical Center	New York	New York
United States	Newark Beth Israel	Newark	New Jersey
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Banner University Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Providence Heart & Vascular Institute	Portland	Oregon
United States	NC Heart and Vascular (Rex Hospital)	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Medical Center	Sacramento	California
United States	Washington University/ Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Kaiser Permanente San Francisco	San Francisco	California
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke	Number of patients that died and/or had a stroke	1 year
Secondary	Mean gradient	Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.	30 days
Secondary	Peak gradient	Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.	30 days
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	30 days
Secondary	New York Heart Association (NYHA) Classification	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.	30 days
Secondary	Six-Minute Walk Test (6MWT)	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.	30 days