Evaluation of cardiac dysfunction after transcatheter aortic valve replacement

Completed

• Conditions: Aortic stenosis; Circulatory System

• Registration Number: ISRCTN33438620
• Lead Sponsor: niversity of Zurich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified