Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction

Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction - CAPTURE AS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48239

Enrollment

Registered

2019-01-24

Start date

2020-11-18

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

severe aortic valve narrowing severe aortic valve narrowing

Interventions

CT scan

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Echocardiographic severe aortic valve stenosis with aortic valve area

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity or contraindication to aspirin, heparin, clopidogrel or sensitivity for contrast media which cannot be adequately pre-medicated 2.Blood dyscrasias as defined: leukopenia (WBC 30 mm per baseline diagnostic imaging 13.sinus of valsalva diameter

Design outcomes

Primary

Measure	Time frame
The co-primary endpoints of this trial are: Change in exercise capacity assessed by CPET (peak VO2) and 6 minute walk test (6MWT) from baseline to 6 months in patients with NF/LG and LF/LG severe AS with preserved LVEF reclassified from severe to moderate AS with fusion AVA 1.0-1.2 cm2.	—

Secondary

Measure	Time frame
The secondary endpoints of this trial in patients with NF/LG and LF/LG severe AS with preserved LVEF reclassified based on hybrid CT/TTE-derived parameters from severe to moderate AS with fusion AVA 1.0-1.2 cm2 and referred for TAVR are: Change in NYHA class and QoL from baseline to 6 months Change in echocardiographic structural and functional characteristics from baseline to 6 months, including: LV dimensions, volumes (2D and 3D if possible) and wall thickness LV systolic and diastolic function parameters Left atrial (LA) dimensions and function RV dimensions, volumes (2D and 3D if possible) and wall thickness RV systolic and diastolic function Pulmonary artery systolic pressure Change in plasma levels of NT-proBNP from baseline to 6 months The secondary endpoints of this trial in patients with NF/LG and LF/LG severe AS with preserved LVEF reclassified based on hybrid CT/TTE-derived parameters from severe to moderate AS with fusion AVA >1.2 cm2 and managed conservatively are: Change in fusion AVA from baseline to 6 months Change in NYHA class and QoL from baseline to 6 months Change in echocardiographic structural and functional characteristics from baseline to 6 months, including: LV dimensions, volumes (2D and 3D if possible) and wall thickness LV systolic and diastolic function LA dimensions and function RV dimensions, volumes (2D and 3D if possible) and wall thickness RV systolic and diastolic function Pulmonary artery systolic pressure Change in plasma levels of NT-proBNP from baseline to 6 months Change in exercise capacity assessed by CPET from baseline to 6 months. *Change in exercise capacity assessed by 6MWT from baseline to 6 months. The secondary endpoints of this trial in patients with LG severe AS with preserved LVEF in whom fusion AVA remains	—

Measure

Time frame

The secondary endpoints of this trial in patients with NF/LG and LF/LG severe AS with preserved LVEF reclassified based on hybrid CT/TTE-derived parameters from severe to moderate AS with fusion AVA 1.0-1.2 cm2 and referred for TAVR are: *Change in NYHA class and QoL from baseline to 6 months *Change in echocardiographic structural and functional characteristics from baseline to 6 months, including: *LV dimensions, volumes (2D and 3D if possible) and wall thickness *LV systolic and diastolic function parameters *Left atrial (LA) dimensions and function *RV dimensions, volumes (2D and 3D if possible) and wall thickness *RV systolic and diastolic function *Pulmonary artery systolic pressure *Change in plasma levels of NT-proBNP from baseline to 6 months The secondary endpoints of this trial in patients with NF/LG and LF/LG severe AS with preserved LVEF reclassified based on hybrid CT/TTE-derived parameters from severe to moderate AS with fusion AVA >1.2 cm2 and managed conservatively are: *Change in fusion AVA from baseline to 6 months *Change in NYHA class and QoL from baseline to 6 months *Change in echocardiographic structural and functional characteristics from baseline to 6 months, including: *LV dimensions, volumes (2D and 3D if possible) and wall thickness *LV systolic and diastolic function *LA dimensions and function *RV dimensions, volumes (2D and 3D if possible) and wall thickness *RV systolic and diastolic function *Pulmonary artery systolic pressure *Change in plasma levels of NT-proBNP from baseline to 6 months *Change in exercise capacity assessed by CPET from baseline to 6 months. *Change in exercise capacity assessed by 6MWT from baseline to 6 months. The secondary endpoints of this trial in patients with LG severe AS with preserved LVEF in whom fusion AVA remains

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Countries

Netherlands

Contacts

Public ContactA Danad

OLVG

A.Danad@olvg.nl0205993440

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)