Assessment of paravalvular leak after transcatheter aortic valve implantation by hemodynamic measurements and cardiac MRI

Recruiting

• Conditions: Aortic Valve Stenosis; 10018031; 10046973

• Registration Number: NL-OMON50145
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients must be >18 years old.
2. Written informed consent is obtained from all patients.
3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s
or Doppler Velocity index <0.25 or an initial aortic valve area (AVA) of <=
1.0cm² (indexed EOA<=06cm²/m²) as measured by trans thoracic echocardiography
<6months prior to inclusion
4. Patients have symptomatic aortic stenosis, as demonstrated by NYHA
functional class 2 or greater or other symptoms of aortic stenosis (e.g.
syncope or angina in the absence of coronary artery disease).
5. Surgical risk is deemed high or intermediate by STS score or by documented
Heart-team agreement due to frailty or co-morbidities.
6. The aortic annulus diameter as measured by ECG-triggered CT-scanning <
6months prior to inclusion meets the ranges indicated in the instructions for
use
7. The access artery diameters (femoral or subclavian) as measured by
CT-scanning < 6 months prior to inclusion meet the ranges indicated in the
instruction for use
8. There are no contra-indications for and patient is willing to undergo
cardiac MRI at discharge to 30 days after TAVI.

Exclusion Criteria

1. Patient is unwilling or unable to comply with study-required follow-up
evaluations
2. There is evidence of a myocardial infarction within 30 days to index
procedure
3. The presence of severe mitral regurgitation or stenosis
4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic
ring in any position
5. Left ventricular ejection fraction (LVEF) less than 30%
6. Untreated significant coronary artery disease requiring revascularization
7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
suggesting active endocarditis
8. The patient is hemodynamically unstable, requiring inotropic or vasopressive
and / or mechanical support
9. The presence of pulmonary edema or intra venous diuretics to stabilize heart
failure at index procedure
10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or
end-stage renal disease requiring dialysis
11. Morbid obesity, defined as a BMI >=40
12. A life expectancy of less than one year.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is defined as PVL regurgitation fraction as measured by<br /><br>cardiac MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint will comprise a composite of device success, early<br /><br>safety and clinical efficacy as defined by the Valve Academic Research<br /><br>Consortium-2 (VARC-2)(1) and will comprise death, vascular complications,<br /><br>stroke/ TIA, life threatening bleeding requiring transfusion, and acute kidney<br /><br>injury requiring dialysis.<br /><br><br /><br>Other secondary endpoint is the effect of TAVI on angiodysplasia. The effect is<br /><br>expressed in difference between hemoglobin level before TAVI and 6 months after<br /><br>TAVI. The difference between blood transfusion and/or iron infusion<br /><br>requirements before and 6 months after TAVI will also be determined.</p><br>