Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

Running, not enrolling · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT02661451

Run by

Cardiovascular Research Foundation, New York

People needed

178

Starts

2016-09-01

Expected to finish

2025-02-01

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All candidates for this study must meet all of the following inclusion criteria:
• Age ≥18 years
• Heart Failure with NYHA class ≥ 2
• 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.
• 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.
• Left ventricular (LV) ejection fraction (EF) < 50% at rest
• Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
• Able to provide independent informed consent (i.e., not requiring a legally authorized representative)

You may not qualify if…

• Candidates are excluded from the study if any of the following conditions are present:
• LVEF < 20% or persistent need for intravenous inotropic support
• Hospitalization for acute decompensated HF within 2 weeks prior to randomization
• Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization
• Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization
• In need and suitable for revascularization per heart team consensus
• Severe aortic and/or mitral regurgitation
• Congenital unicuspid or congenital bicuspid aortic valve
• Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA)
• Previous aortic valve replacement (mechanical or bioprosthetic)
• Severe RV dysfunction
• Previous stroke with permanent disability (modified Rankin score ≥ 2)
• Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime supplemental oxygen therapy
• Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy
• Gastrointestinal (GI) bleeding within the past 3 months
• Liver cirrhosis Child-Pugh C
• Active systemic infection, including active endocarditis
• Unwilling to accept blood transfusion
• Evidence of intracardiac mass, thrombus or vegetation
• Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
• Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation)
• Sensitivity to contrast media which cannot be adequately pre-medicated
• Women of child-bearing potential
• Clinical signs of dementia
• Other medical, social, or psychological conditions that precludes appropriate consent and follow-up

Where it is running

• UCSD/Sulpizio Cardiovascular Center — La Jolla, California, United States
• University of Southern California - Los Angeles — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• St. Joseph Hospital — Orange, California, United States
• UCSF — San Francisco, California, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, 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
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• Ascension St. Mary's Hospital — Saginaw, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• HealthEast Medical Research Institute — Saint Paul, Minnesota, United States
• Chandler Regional Medical Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.