EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Heart Diseases Clinical Trial

— EARLY TAVR  

Official title:

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03042104
• Other study ID #: 2016-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: March 2032

Study information

• Verified date: May 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Description:

This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 901
• Est. completion date: March 2032
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. 65 years of age or older

2. Severe aortic stenosis

3. Patient is asymptomatic

4. LV ejection fraction = 50%

5. Society of Thoracic Surgeons (STS) risk score = 10

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. Patient is symptomatic

2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.

3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV

4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.

5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR

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

7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified

8. Severe aortic regurgitation (>3+)

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

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

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

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

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

14. Hypertrophic cardiomyopathy with obstruction

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

16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy

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

18. Renal insufficiency and/or renal replacement therapy

19. Active bacterial endocarditis within 180 days of randomization

20. Severe lung disease or currently on home oxygen

21. Severe pulmonary hypertension

22. History of cirrhosis or any active liver disease

23. Significant frailty as determined by the Heart Team

24. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system

25. Patient refuses blood products

26. BMI >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. Currently participating in an investigational drug or another device study.

30. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Diseases

Intervention

Device:
• Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Albany Medical College	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University at Buffalo - Kaleida Health	Buffalo	New York
United States	Mills Peninsula Health Services	Burlingame	California
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Carolina's Health System	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center Chicago	Chicago	Illinois
United States	The Christ Hospital, Cincinnati	Cincinnati	Ohio
United States	Kaiser Portland	Clackamas	Oregon
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mount Carmel Health System	Columbus	Ohio
United States	The Ohio Health Research Institute	Columbus	Ohio
United States	Texas Health Physician Group	Dallas	Texas
United States	The Heart Hospital Baylor Plano	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	NorthShore University HealthSystem Research Institution	Evanston	Illinois
United States	Providence Everett	Everett	Washington
United States	Inova Heart and Vascular Institute (Fairfax Inova)	Falls Church	Virginia
United States	The Cardiac & Vascular Institute Research Foundation	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Pinnacle Health	Harrisburg	Pennsylvania
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
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	Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire
United States	Alexian Brothers Hospital Network	Lisle	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	NYU Langone Hosptial - Long Island	Mineola	New York
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Atlantic Health System Hospital Corp - Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center Salt Lake City	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
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 Langone Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Huntington Hospital	Pasadena	California
United States	Banner University Medical Center	Phoenix	Arizona
United States	Rutgers Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	Allegheny - Singer Research Institute	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	NC Heart and Vascular (Rex Hospital)	Raleigh	North Carolina
United States	Carilion Medical Center	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	UC Davis Medical Center	Sacramento	California
United States	CentraCare Heart	Saint Cloud	Minnesota
United States	Kaiser San Francisco Medical Center	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stanford Hospital and Clinics Palo Alto	Stanford	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Washington Hospital Center DC	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
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,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death, all stroke, and unplanned cardiovascular hospitalization	The number of patients that have any of these conditions	When all patients have reached 2-year follow-up
Secondary	Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score =75 and 3) KCCQ decrease =10 points	The number of patients that meet all of these criteria	2 years
Secondary	Left Ventricular Health	Echocardiographic measurements that will assess the health of the left ventricle	2 years
Secondary	Change in Left Ventricular Ejection Fraction (LVEF)	The average change in LVEF from baseline	2 years
Secondary	New onset atrial fibrillation	The number of patients that develop this condition	When all patients have reached 2-year follow-up
Secondary	Death or disabling stroke	The number of patients that have any of these conditions	When all patients have reached 2-year follow-up