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New treatment option for Aortic Valve Stenosis
Official title Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
ClinicalTrials.gov ID: NCT06603454
What this study is testing
- What it's testing
- Rationale When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not yet part of routine clinical practice in SAVR patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of \<1.0cm2 and either a mean valve gradient of at least 40mmHg or...
- Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional...
- Informed consent
You likely can't join if
- Previous aortic valve replacement
- Emergency procedure
- Pregnant women
- Renal failure (eGFR \<30 ml/min.)
- Known contrast allergy
- Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan
See the full eligibility criteria
- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of \<1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak velocity of at least 4.0 m/s)
- Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional median sternotomy approach at the preference of the patient and/or the...
- Informed consent
- Previous aortic valve replacement
- Emergency procedure
- Pregnant women
- Renal failure (eGFR \<30 ml/min.)
- Known contrast allergy
- Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan
- Contra-indication for MRI (e.g. permanent pacemaker or ICD that can not be inactivated per order of the pacemaker or ICD technician, morphine or insulin pump, neurostimulator). All patients will fill out a MRI checklist...
- Patient who did not agree to the informed consent and/or refused to participate
- Patient unable to understand the informed consent/study
The study team makes the final eligibility decision.
Where it's taking place
- Nieuwegein, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nieuwegein, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.