Aortic stenosis Circulatory System Aortic stenosis
Conditions
Interventions
Pre-procedure, all patients will undergo TTE and Cardiac CT according to routine practice, to determine the indications for the procedure and compliance with the inclusion/exclusion criteria of the st
Sponsors
University of Zurich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed Consent as documented by signature 2. Severe, symptomatic, calcific aortic stenosis who meet the commercially approved indications for TAVR 3. NYHA Functional Classification of II, III, or IV 4. Echocardiographic criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of < 0.8 cm2 (indexed EOA < 0.5 cm2/m2) 5. LVEF <40% as measured by resting echocardiogram 6. Patient is suitable for PV Loop procedure; no contraindication to Jugular vein and carotid artery cannulation 7. Aged 18-95 years
Exclusion criteria
Exclusion criteria: 1. Any contraindication to TAVR procedure. 2. Low flow, low gradient aortic stenosis (LF/LGAS) (defined as an effective orifice area <1.0cm2 LV ejection fraction <40%, and mean pressure difference <30mmHg). 3. Hemodynamic instability at hospital admission, need for emergency surgery or intervention. 4. Bicuspid or unicuspid aortic valve 5. Other type of severe valve disease such as aortic regurgitation, mitral stenosis or mitral regurgitation 6. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe mitral annular calcification (MAC), or severe (greater than 3+) mitral insufficiency. 7. Acute myocardial infarction (<30 days prior to procedure) 8. Atrial fibrillation 9. Life expectancy < 12 months 10. Vulnerable subjects / incapable of giving consent 11. Paravalvular Leak
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular contractility is measured by conductance catheters before and after TAVR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Indexes of systolic function are derived by Transesophageal Echocardiography (TEE) before and after TAVR 2. Ventricular remodeling after the intervention is measured by comparing parameters derived from Transthoracic Echocardiography (TTE) at baseline and 3 months | — |
Countries
Switzerland
Contacts
Public ContactAndrea Guidotti
Outcome results
None listed