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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Age ≥ 18 years.
  • NYHA class ≥ 2.
  • NT-proBNP > 900 pg/mL (or BNP > 200 pg/mL) or hospitalization for HF within previous two years.
    • Note: To account for decrease in natriuretic peptide levels with overweight/obesity NT-proBNP and BNP levels cutoff will be reduced by 4% for every increase of 1 kg/m^2 in BMI above a reference BMI of 20 kg/m^2).
  • Under appropriate and stable guideline-directed HF therapy (including cardiac resynchronization therapy) for a minimum of 1 month.
    • Note:  Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for heart failure. 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 cm^2 and ≤1.5 cm^2 on rest echo or if ≤1.0 cm^2 at rest and low flow AS is suspected an AVA > 1.0 cm^2 with low dose dobutamine stress echo (DSE). Patients with AVA < 1.0 cm^2 but with an indexed AVA of >0.6cm^2 on either rest or DSE are also eligible.  imilarly, patients with AVA >1.5 cm2 but with indexed AVA < 0.9 cm^2/m^2 on either rest ofr DSE are also eligible. 
    • Note: Typically such cases will demonstrate:
      • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valvevalve area (AVA) > 1.0 cm2 and ≤1.5 cm^2 (or AVA < 1.0 cm^2 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 cm^2 at rest AND MG < 40 mmHg and aortic valve area (AVA) >1.0 cm^2 (or AVA < 1.0 cm^2 but indexed AVA > 0.6 cm^2) 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, or in case of BSA being elevated due to obesity, the final eligibility determination in regards to diagnosis of moderate AS will be made by the echocardiographic core lab.
  • In indeterminate cases calcium score may also be used to assess the presence of moderate AS.
  • 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).

 

Exclusion Criteria:

 

 

  • 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 31 months prior to randomization.
  • Coronary artery revascularization (PCI or CABG) within 31 months 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.
  • Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases.
  • Unwillingness to undergo follow-up investigations .
  • Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vuyisile Nkomo, M.D., M.P.H.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20392040

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