PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Aortic Stenosis Clinical Trial

— P3  

Official title:

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02675114
• Other study ID #: 2015-08
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Description:

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2029
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Severe, calcific aortic stenosis

2. New York Heart Association Functional Class = 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%

3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4

4. 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. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve

2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath

3. Evidence of an acute myocardial infarction = 30 days before randomization

4. Aortic valve is unicuspid, bicuspid, or non-calcified

5. Severe aortic regurgitation (>3+)

6. Severe mitral regurgitation (>3+) = moderate stenosis

7. Pre-existing mechanical or bioprosthetic valve in any position

8. Complex coronary artery disease:

1. Unprotected left main coronary artery

2. Syntax score > 32

3. Heart Team assessment that optimal revascularization cannot be performed

9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization

10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states

11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization

12. Hypertrophic cardiomyopathy with obstruction

13. Ventricular dysfunction with LVEF < 30%

14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure

16. Stroke or transient ischemic attack within 90 days of randomization

17. Renal insufficiency and/or renal replacement therapy at the time of screening.

18. Active bacterial endocarditis within 180 days of randomization

19. Severe lung disease or currently on home oxygen

20. Severe pulmonary hypertension

21. History of cirrhosis or any active liver disease

22. Significant frailty as determined by the Heart Team

23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement

24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation

25. Patient refuses blood products

26. Body mass index > 50 kg/m2

27. Estimated life expectancy < 24 months

28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication

29. Immobility that would prevent completion of study procedures

30. Patient is not a candidate for both arms of the study

31. Currently participating in an investigational drug or another device study.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• SAVR
SAVR with a commercially available bioprosthetic valve.

Device:
• SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Canada	Saint Paul's Hospital	Vancouver
Japan	Teikyo University	Itabashi	Tokyo
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Keio University	Shinjuku	Tokyo
Japan	Osaka University	Suita	Osaka
New Zealand	Auckland City Hospital	Grafton	Auckland
United States	Albany	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	JFK Medical Center / Atlantic Clinical Research Collaborative	Atlantis	Florida
United States	Central Maine Medical Center	Auburn	Maine
United States	Austin Heart	Austin	Texas
United States	University of Alabama	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Mills/Peninsula Health Services	Burlingame	California
United States	Carolina's Health System	Charlotte	North Carolina
United States	UPR - Novant Health Heart and Vascular Institution	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital, Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mount Carmel Health System	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	NorthShore University HealthSystem Research Institute	Evanston	Illinois
United States	Fairfax INOVA	Falls Church	Virginia
United States	University of Florida, Gainesville	Gainesville	Florida
United States	Hartford	Hartford	Connecticut
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
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	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles/Ronald Reagan Medical Center	Los Angeles	California
United States	UC Health Northern Colorado/Medical Center of the Rockies	Loveland	Colorado
United States	University of Wisconsin	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Winthrop-University Hospital	Mineola	New York
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Morristown Medical Center / Atlantic Health System Hospital	Morristown	New Jersey
United States	Saint Thomas Health Services	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	UPR - Louisiana State University Health Science Center	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	NYU Medical Center	New York	New York
United States	Newark Beth Israel	Newark	New Jersey
United States	Hoag Hospital	Newport Beach	California
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	The Heart Hosptial Baylor Plano	Plano	Texas
United States	Providence Heart & Vascular Institute	Portland	Oregon
United States	Rex Hospital / NC Heart and Vascular Research	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Health Sacramento	Sacramento	California
United States	Barnes-Jewish Hospital / Washington University	Saint Louis	Missouri
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	Kaiser Permanente San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	UPR-Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)	Number of patients that had any of these events	1 year
Secondary	New Onset Atrial Fibrillation	Number of patients with this event	30 days
Secondary	Length of Index Hospitalization	Number of days from index procedure to discharge	Discharge (expected average of 7 days)
Secondary	Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease = 10 Points	Number of patients that had any of these events	30 days
Secondary	Death or Stroke	Number of patients that died or had a stroke	30 days
Secondary	All Stroke	Number of patients that had a stroke	30 days