Evaluation of the native aortic root pre-procedure and prosthesis geometry post implantation by MSCT to guide prosthesis size selection before percutaneous aortic valve replacement

Evaluation of the native aortic root pre-procedure and prosthesis geometry post implantation by MSCT to guide prosthesis size selection before percutaneous aortic valve replacement - MSCT-PCVR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33154

Enrollment

150

Registered

2009-08-05

Start date

2009-08-11

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

artificial aortic valve

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient scheduled for percutaneous Aortic valve replacement

Exclusion criteria

Exclusion criteria: - Severe allergy to radiocontrast (previous anaphylaxis/angio-oedema) - Severely irregular heart rhythm precluding diagnostic MSCT images - Inability to breath hold for the duration of an MSCT scan - Patients with severe renal impairment (estimated GFR below 20ml/min) will not be eligible for MSCT with contrast

Design outcomes

Primary

Measure	Time frame
To determine which dimensions of the aortic root are optimal to guide prosthesis size selection	—

Secondary

Measure	Time frame
- The quantitative and qualitative assessment of the geometry and degree of deformation of the PAVR prostheses with MSCT - To investigate the association between aortic regurgitation (valvular and para-valvular) post PAVR and 1) prosthesis sizing (degree of expansion, asymmetry and apposition) and 2) position (depth of implantation)	—

Countries

Netherlands

Outcome results