INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantation

INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantation - INVA-SOUND-MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56835

Enrollment

Registered

2024-06-19

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bioprosthetic heart valve TAVI

Interventions

The intervention involves a 4D flow MRI scan in which intravenous gadolinium contrast is administered (0.2 mmol/kg).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult patient (>18 years) - Post TAVI procedure - Successful TAVI with no unresolved procedure related complications (VARC-3 definition) o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is the transprosthetic aortic gradient by 4D flow MRI.	—

Secondary

Measure	Time frame
Echocardiography derived: • Mean aortic pressure gradient (PG) (mmHg) • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) Invasive: • Mean aortic pressure gradient (PG) (mmHg) • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) 4D Flow MRI derived: • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) • Wall shear stress (Pa) • Energy loss (mW) • Flow eccentricity • LV ejection fraction (%) • LV enddiastolic volume (ml) • LV endsystolic volume (ml) • LV stroke volume (ml) • Ascending aortic diameter (mm) For all included patients, baseline (medical) details will also be obtained from patient records including age, sex, body mass index (BMI), relevant medical history (including chronic obstructive pulmonary disease, asthma, kidney failure, any previous malignancy, hypertension, diabetes mellitus, hypercholesterolemia, cerebrovascular accident or transient ischemic attack, any pre-existing supraventricular or ventricular rhythm disturbances, assessment of valvulopathy, myocardial infarction or coronary artery bypass graft and NYHA class of functional impairment. Kidney (dys)function prior to the intervention will be graded according to the 2005 KDIGO guidelines. Results of routine laboratory testing prior to the scheduled intervention will be evaluated for all patients, including haemoglobin (mmol L-1), creatinine level (µmol L-1), estimated glomerular filtration rate (e-GFR, ml min-1), high sensitive troponin-T (ng L-1), C-reactive protein (CRP, mg L-1) and leucocyte count (109 L-1).	—

Measure

Time frame

Echocardiography derived: • Mean aortic pressure gradient (PG) (mmHg) • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) Invasive: • Mean aortic pressure gradient (PG) (mmHg) • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) 4D Flow MRI derived: • Peak aortic pressure gradient (PG) (mmHg) • Peak aortic velocity (m/s) • Wall shear stress (Pa) • Energy loss (mW) • Flow eccentricity • LV ejection fraction (%) • LV enddiastolic volume (ml) • LV endsystolic volume (ml) • LV stroke volume (ml) • Ascending aortic diameter (mm) For all included patients, baseline (medical) details will also be obtained from patient records including age, sex, body mass index (BMI), relevant medical history (including chronic obstructive pulmonary disease, asthma, kidney failure, any previous malignancy, hypertension, diabetes mellitus, hypercholesterolemia, cerebrovascular accident or transient ischemic attack, any pre-existing supraventricular or ventricular rhythm disturbances, assessment of valvulopathy, myocardial infarction or coronary artery bypass graft and NYHA class of functional impairment. Kidney (dys)function prior to the intervention will be graded according to the 2005 KDIGO guidelines. Results of routine laboratory testing prior to the scheduled intervention will be evaluated for all patients, including haemoglobin (mmol L-1), creatinine level (µmol L-1), estimated glomerular filtration rate (e-GFR, ml min-1), high sensitive troponin-T (ng L-1), C-reactive protein (CRP, mg L-1) and leucocyte count (109 L-1).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)