TAVR UNLOAD

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

Inclusion Criteria

• Under appropriate guideline-directed HF therapy(including cardiac resynchronization therapy) for a minimum of 3 months.
  • 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 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 on either rest or DSE are also eligible.
• Left ventricular (LV) ejection fraction (EF) < 50% at rest

Exclusion Criteria

• LVEF < 20% or persistent need for intravenous inotropic support
• Hospitalization for acute decompensated HF within 2 weeks prior to randomization
• Previous aortic valve replacement (mechanical or bioprosthetic)

Study Requirements

Baseline before enrollment in the study:

• Blood tests will be drawn to rule out infection, to check for normal red blood cell and platelet count, and to measure your level of HF. If you are in the TAVR group, additional testing of cardiac markers in your blood will be drawn.We will draw about the equivalent of a table poon (15 ml)
• Electrocardiogram (ECG)
• Dobutamine Stress echocardiogram
• Pulmonary function test
• 6 minute walk test to measure your exercise tolerance.
• Kansas City Cardiac Questionnaire (KCCQ) to measure physical limitations and symptoms that are potentially related to chronic heart conditions.
• Additional Quality of Life and Frailty questionnaires
• Neurological Assessment, which may include an additional CT scan or MRI of the brain to confirm or rule-out a prior stroke per routine clinical practice (SOC). .
• At the discretion of the investigator or If you have a confirmed prior diagnosis of respiratory disease, specifically COPD, a Pulmonary Function Test (PFT a machine called a spirometer is used to measure your lung capacity and see if your lungs are working within normal limits) may be taken to determine or re-confirm COPD status.
• A multidetector computed tomography (MDCT) chest and abdominal
• A transesophageal echocardiogram (TEE) may be performed to allow for a better view of your heart valve and chambers test It is a more invasive procedure than the Transthoracic echocardiogram(TTE)
• Chest x-ray
• Coronary Angiogram

Follow up Post procedure if assigned to the TAVR group

• Blood tests will be drawn to rule out infection, to check for normal red blood cell and platelet count, and to measure your level of HF and additional testing of cardiac markers in your blood will be drawn.We will draw about the equivalent of a table poon (15 ml)
• Echorcariogram (TTE or TEE is suboptimal images)
• Neurological assessment
• ECG

At 30 days, 6 months and year 1 and 2 post procedure

• Targeted Physical Exam
• 12 lead ECG / rhythm strip
• Neurological Exam
• 6 minute walk test
• Kansas City Cardiac Questionnaire (KCCQ)
• Quality of Life and Frailty Questionnaires
• Laboratory Tests to assess overall health condition
• Echocardiography (TTE or TEE) including assessment of THV function