Calibration of time-densitometry for the quantification of aortic regurgitation

Calibration of time-densitometry for the quantification of aortic regurgitation - IQ-AR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41724

Enrollment

Registered

2015-06-01

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

aortic valve insufficieny aortic valve leak aortic valve regurgitation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >18y 2. At least mild (grade 1 or more) aortic regurgitation (AR) on contrast aortography or echocardiography 3. Per protocol Contrast aortography 4. Contrast aortography meets all the image quality criteria that allows quantification of AR by qRA 5. Cardiac MRI (CMRI) can be performed within 1 week of aortography 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Advanced renal impairment that precludes contrast aortography (eGFR

Design outcomes

Primary

Measure	Time frame
1. Regurgitant volume and regurgitant fraction measured by velocity encoded MRI 2. qRA-index measured on aortography	—

Secondary

Measure	Time frame
1. Semi-quantitative TTE measurements a. in patients without TAVI or pre-TAVI: i. Vena contracta (VC) width (mm) ii. Pressure half-time (PHT) (ms) b. only in case of TAVI: Post-TAVI: i. Circumferential extent of prosthetic valve paravalvular regurgitation ii. Diastolic flow reversal in the descending aorta 2. Quantitative TTE(pre-) / TOE (post) measurements (only in case of TAVI: pre- and post-TAVI) a. Effective regurgitant orifice area (EROA) (mm2) b. Regurgitant Volume (RV) (ml) 3. Sinning index / (AR-index) calculated from haemodynamic pressure measurements	—

Measure

Time frame

1. Semi-quantitative TTE measurements a. in patients without TAVI or pre-TAVI: i. Vena contracta (VC) width (mm) ii. Pressure half-time (PHT) (ms) b. only in case of TAVI: Post-TAVI: i. Circumferential extent of prosthetic valve paravalvular regurgitation ii. Diastolic flow reversal in the descending aorta 2. Quantitative TTE(pre-) / TOE (post) measurements (only in case of TAVI: pre- and post-TAVI) a. Effective regurgitant orifice area (EROA) (mm2) b. Regurgitant Volume (RV) (ml) 3. Sinning index / (AR-index) calculated from haemodynamic pressure measurements

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Countries

Netherlands

Outcome results