Clinical Studies
First-in-Human Experience: Patient 1
Medical history: 82 years old woman, referred to consider TAVI because of severe symptomatic Aortic Stenosis. It was discovered in a preoperative evaluation for the treatment of a giant AAA.
Symptoms: Short of breath FC II, (NYHA)
Treatment: TAVI from femoral conduit approach 18F introducer from right femoral conduit TAVI implant with Onecrea 26 mm valve under rapid pacing, 4-6 mm depth in the LVOT
Outcome: Final V.Max of 2.0 m/s, Mean Gradient 8 mmHg, Peak Gradient 18 mmHg, Trivial PVL
Crea Aortic Valve crossing the aortic arch
Crea Aortic Valve positioning
First-in-Human Experience: Patient 2
Medical history: 88 years old woman, referred to consider TAVI because of severe symptomatic
Aortic stenosis. She was recently admitted in the emergency room in heart failure requiring mechanical ventilation. The diagnosis of severe aortic stenosis was done. BAV was done and PCI plus stent of the left main. She was discharged after 5 days.
Symptoms: Short of breath FC II, (NYHA)
Treatment: TAVI from femoral conduit approach 18F introducer from right femoral conduit
TAVI implant with Onecrea 26 mm valve under rapid pacing, 4-6 mm depth in the LVOT
Outcome: Final V.Max of 1.86 m/s, Mean Gradient 7 mmHg, Peak Gradient 14 mmHg, No PVL