Research Study: TAVR UNLOAD
Condition:
aortic valve stenosis
Study Sponsor: Cardiovascular Research Foundation
Study Investigator: Santiago Garcia, MD
Study Contact: Jenny Nguyen
jennifer.nguyen@allina.com
612-863-9291
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
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.
Eligibility Criteria:

  • Age ≥18 years
  • NYHA class ≥ 2
  • NT-proBNP > 900pg/mL (or BNP > 200 pg/mL) or hospitalization for HF within the 2 years;
    • Note: To account for the 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/m2 in BMI above a reference BMI of 20 kg/m2).
  • Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month. o 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)

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!