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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02661451
Other study ID # TAVR Unload
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date February 2025

Study information

Verified date July 2023
Source Cardiovascular Research Foundation, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 178
Est. completion date February 2025
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria All candidates for this study must meet all of the following inclusion criteria: 1. Age =18 years 2. Heart Failure with NYHA class = 2 3. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization. Note: Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for heart failure. (12, 13) Patients with aortic stenosis may not be able to tolerate maximal doses of heart failure medications and no specific guidelines exist for the medical treatment of heart failure in the setting of aortic stenosis. It is expected that the heart failure PI will review the medical therapy and confirm that it is appropriate for the patient's condition. 4. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) >1.0 cm2 and =1.5 cm2 on rest echo or if =1.0 cm2 at rest and low-flow AS is suspected when the an AVA > 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA<1.0 cm2 but with an indexed AVA of >0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients with AVA >1.5 cm2 but with indexed AVA<0.9 cm2/m2 on either rest of DSE are also eligible. Note: Typically such cases will demonstrate, • Mean trans-aortic gradient (MG) = 20 mmHg and < 40 mmHg at rest and aortic valve area (AVA) > 1.0 cm2 and =1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest OR • Mean trans-aortic gradient (MG) = 20 mmHg and < 40 mmHg and aortic valve area (AVA) =1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA) •>1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) with low dose dobutamine stress echo (DSE). In atypical cases (for example mean gradient is below 20 mmHg but valve area is consistent with moderate AS, the final eligibility determination in regards to diagnosis of moderate AS will be made by the echocardiographic core lab. 5. Left ventricular (LV) ejection fraction (EF) < 50% at rest 6. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV 7. Able to provide independent informed consent (i.e., not requiring a legally authorized representative) Exclusion Criteria Candidates are excluded from the study if any of the following conditions are present: 1. LVEF < 20% or persistent need for intravenous inotropic support 2. Hospitalization for acute decompensated HF within 2 weeks prior to randomization 3. Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization 4. Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization 5. In need and suitable for revascularization per heart team consensus 6. Severe aortic and/or mitral regurgitation 7. Congenital unicuspid or congenital bicuspid aortic valve 8. Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA) 9. Previous aortic valve replacement (mechanical or bioprosthetic) 10. Severe RV dysfunction 11. Previous stroke with permanent disability (modified Rankin score = 2) 12. Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime supplemental oxygen therapy 13. Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy 14. Gastrointestinal (GI) bleeding within the past 3 months 15. Liver cirrhosis Child-Pugh C 16. Active systemic infection, including active endocarditis 17. Unwilling to accept blood transfusion 18. Evidence of intracardiac mass, thrombus or vegetation 19. Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV 20. Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation) 21. Sensitivity to contrast media which cannot be adequately pre-medicated 22. Women of child-bearing potential 23. Clinical signs of dementia 24. Other medical, social, or psychological conditions that precludes appropriate consent and follow-up 25. Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases 26. Unwillingness to undergo follow-up investigations 27. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SAPIEN 3 THV

Biological:
Optimal Heart Failure Therapy


Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario
Netherlands Leiden University Medical Center Leiden
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht TH
Netherlands Isala Clinics Zwolle
United States Seton Medical Center Austin Austin Texas
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States University of Vermont Medical Center Burlington Vermont
United States Chandler Regional Medical Center Chandler Arizona
United States Advocate Christ Hospital Chicago Illinois
United States Northwestern University Chicago Illinois
United States Alexian Brothers Medical Center Elk Grove Village Illinois
United States Evanston Hospital/NorthShore Univ. Health System Evanston Illinois
United States UCSD/Sulpizio Cardiovascular Center La Jolla California
United States UCLA Medical Center Los Angeles California
United States University of Southern California - Los Angeles Los Angeles California
United States Medical Center of the Rockies Loveland Colorado
United States University of Miami Miami Florida
United States Advocate Aurora- St. Lukes Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Oklahoma Heart Hospital Milwaukee Wisconsin
United States Minneapolis Heart Institute Minneapolis Minnesota
United States Morristown Memorial Morristown New Jersey
United States IHC Health Services, Inc. dba Intermountain Medical Center Murray Utah
United States Vanderbilt Heart and Vascular Nashville Tennessee
United States Yale University New Haven Connecticut
United States Columbia University Medical Center/New York Presbyterian Hospital New York New York
United States NYU Langone Medical Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States St. Joseph Hospital Orange California
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States University of Pennsylvania Philadelphia Pennsylvania
United States UPMC Presbyterian Pittsburgh Pennsylvania
United States Maine Medical Center Portland Maine
United States Oregon Health Science University (OHSU) Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Virginia Commonwealth University (VCU) Richmond Virginia
United States Mayo Clinic - Rochester Rochester Minnesota
United States St. Francis Hospital Roslyn New York
United States Beaumont Hospital Royal Oak Michigan
United States Ascension St. Mary's Hospital Saginaw Michigan
United States Washington University in St. Louis Saint Louis Missouri
United States HealthEast Medical Research Institute Saint Paul Minnesota
United States UCSF San Francisco California
United States Swedish Medical Center Seattle Washington
United States Carle Foundation Hospital Urbana Illinois
United States Medstar Washington Hospital Center Washington District of Columbia
United States Cleveland Clinic Florida Weston Florida
United States PinnacleHealth Cardiovascular Institute Wormleysburg Pennsylvania
United States WellSpan York Hospital York Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Cardiovascular Research Foundation, New York Avania, Cardialysis BV

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-Cause Death Hierarchical occurrence within efficacy assessment time interval (EATI) of: 12 months
Primary Disabling Stroke Hierarchical occurrence within efficacy assessment time interval (EATI) of: 12 months
Primary Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent). Hierarchical occurrence within efficacy assessment time interval (EATI) of: 12 months
Primary Change in KCCQ relative to baseline Hierarchical occurrence within efficacy assessment time interval (EATI) of: 12 months
Secondary MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of: All-cause death
Disabling stroke
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)
12 month
Secondary -All-cause death within EATI -All-cause death within EATI 12 month
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