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

Not Applicable

Active, not recruiting

• Conditions: Aortic Stenosis, Severe; Heart Diseases

• Registration Number: NCT03042104
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Study Start: 2017-07-12
• Primary Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Completion: 2032-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 901

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-cause death, all stroke, and unplanned cardiovascular hospitalization	When all patients have reached 2-year follow-up	The number of patients that have any of these conditions

Secondary Outcome Measures

Name	Time	Method
Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points	2 years	The number of patients that meet all of these criteria
Left Ventricular Health	2 years	Echocardiographic measurements that will assess the health of the left ventricle
Change in Left Ventricular Ejection Fraction (LVEF)	2 years	The average change in LVEF from baseline
New onset atrial fibrillation	When all patients have reached 2-year follow-up	The number of patients that develop this condition
Death or disabling stroke	When all patients have reached 2-year follow-up	The number of patients that have any of these conditions

Trial Locations

Locations (77)

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

Mills Peninsula Health Services; 🇺🇸 Burlingame, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Huntington Hospital; 🇺🇸 Pasadena, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Kaiser San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Stanford Hospital and Clinics Palo Alto; 🇺🇸 Stanford, California, United States

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

Yale University; 🇺🇸 New Haven, Connecticut, United States

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