Status:
ACTIVE_NOT_RECRUITING
Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI
Lead Sponsor:
Radboud University Medical Center
Conditions:
Transcatheter Aortic Valve Replacement
Hemodynamic Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively common and there ...
Detailed Description
1. INTRODUCTION AND RATIONALE Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients with severe symptomatic aortic valve stenosis and increased surgical ri...
Eligibility Criteria
Inclusion
- Patients must be \>18 years old.
- Written informed consent is obtained from all patients.
- 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≤06 cm²/m²) as measured by trans thoracic echocardiography \<6months prior to inclusion.
- Patients have symptomatic aortic stenosis, as demonstrated by New York Heart Association (NYHA) functional class 2 or greater or other symptoms of aortic stenosis (e.g. syncope or angina in the absence of coronary artery disease).
- Surgical risk is deemed high or intermediate by Society of Thoracic Surgery (STS) risk score or by documented Heart-team agreement due to frailty or co-morbidities.
- The aortic annulus diameter as measured by ECG-triggered CT-scanning \< 6months prior to inclusion meets the ranges indicated in the instructions for use.
- 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.
- There are no contra-indications (e.g.: severe claustrophobia, metal implants, severe renal failure) for and patient is willing to undergo cardiac MRI at discharge to 30 days after TAVI.
Exclusion
- Patient is unwilling or unable to comply with study-required follow-up evaluations.
- There is evidence of a myocardial infarction within 30 days to index procedure.
- The presence of severe mitral regurgitation or stenosis.
- The presence of pre-existing prosthetic cardiac device, valve or prosthetic ring in any position.
- Left ventricular ejection fraction (LVEF) less than 30%.
- Untreated significant coronary artery disease requiring revascularization.
- Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation suggesting active endocarditis.
- The patient is hemodynamically unstable, requiring inotropic or vasopressive and / or mechanical support.
- The presence of pulmonary edema or intra venous diuretics to stabilize heart failure at index procedure.
- Renal insufficiency, defined as a serum creatinin greater than 250umol/l or end-stage renal disease requiring dialysis.
- Morbid obesity, defined as a BMI ≥40.
- A life expectancy of less than one year.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04281771
Start Date
September 17 2019
End Date
October 28 2026
Last Update
January 19 2024
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands, 6525 GA