Preoperative chest CT-imaging in surgical aortic valve replacement with or without CABG: a randomized controlled trial.

Preoperative chest CT-imaging in surgical aortic valve replacement with or without CABG: a randomized controlled trial. - GUIDE-SAVR

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56045

Enrollment

380

Registered

2022-11-04

Start date

2023-11-09

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

aortic valve stenosis

Interventions

Low-dose contrast-enhanced CT of the total aorta

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of

Exclusion criteria

Exclusion criteria: - Previous aortic valve replacement - Emergency procedure - Pregnant women - Patient unwilling to be informed about unrequested findings on the CT-scan or MRI-scan - Contra-indication for MRI - Patient who did not agree to the informed consent and/or refused to participate - Patient unable to understand the informed consent/study

Design outcomes

Primary

Measure	Time frame
- Subclinical stroke rate (i.e., presence of new ischemic brain lesions) as identified with the use of DW-MRI made within one week postoperatively or before discharge	—

Secondary

Measure	Time frame
- National Institutes of Health Stroke Scale (NIHSS) score one week postoperatively or before discharge (assessment will be performed by a neurologist). - Clinical ischemic stroke (conform VARC-3) diagnosed by a neurologist one week postoperatively or before discharge - TIA diagnosed by a neurologist one week postoperatively or before discharge (conform VARC-3). - Mortality at 30 days - Change in intervention strategy (no unfavourable change, cancellation of surgery (before or after sternotomy), switch to TAVR preprocedural, conversion from limited access to conventional full median sternotomy, conversion to TAVR) - Change in cannulation strategy (no change, use of different cannula, avoiding cannulation of the ascending aorta/arch (thus femoral or subclavian cannulation), higher cannulation (arch), lower cannulation, echo-guided cannulation) - Change in clamping strategy (no change, change of clamping site, no clamping) - Procedural times: Implantation time (defined period from start of the valve assessment until the completion of the prosthesis implantation = fixation of last suture), surgical time, aortic cross-clamp (ACC) time, cardio-pulmonary bypass (CPB) time - Quality of life (assessed by EQ-5D and KCCQ) at baseline and at two-month follow-up - Fractional flow reserve derived from MSCT (only in patients who are randomized to preoperative MSCT) - Fractional flow reserve measured with standard preprocedural coronary angiography (only in patients who are randomized to preoperative MSCT)	—

Measure

Time frame

- National Institutes of Health Stroke Scale (NIHSS) score one week postoperatively or before discharge (assessment will be performed by a neurologist). - Clinical ischemic stroke (conform VARC-3) diagnosed by a neurologist one week postoperatively or before discharge - TIA diagnosed by a neurologist one week postoperatively or before discharge (conform VARC-3). - Mortality at 30 days - Change in intervention strategy (no unfavourable change, cancellation of surgery (before or after sternotomy), switch to TAVR preprocedural, conversion from limited access to conventional full median sternotomy, conversion to TAVR) - Change in cannulation strategy (no change, use of different cannula, avoiding cannulation of the ascending aorta/arch (thus femoral or subclavian cannulation), higher cannulation (arch), lower cannulation, echo-guided cannulation) - Change in clamping strategy (no change, change of clamping site, no clamping) - Procedural times: Implantation time (defined period from start of the valve assessment until the completion of the prosthesis implantation = fixation of last suture), surgical time, aortic cross-clamp (ACC) time, cardio-pulmonary bypass (CPB) time - Quality of life (assessed by EQ-5D and KCCQ) at baseline and at two-month follow-up - Fractional flow reserve derived from MSCT (only in patients who are randomized to preoperative MSCT) - Fractional flow reserve measured with standard preprocedural coronary angiography (only in patients who are randomized to preoperative MSCT)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)