RecruitingNot Applicable

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

Japan800 participantsStarted 2025-06-01

Plain-language summary

To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.

Who can participate

SexALL

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Inclusion criteria

✓. All study participants must meet the following inclusion criteria 1. Severe, calcific aortic stenosis with the following criteria:
✓. The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately captured by risk calculators such as STS-PROM, in addition to the risk score itself.
✓. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.

Exclusion criteria

✕. History of cardiovascular surgery or thoracotomy
✕. Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary.
✕. Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.
✕. Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.
✕. Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.
✕. Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization
✕. Aortic valve is unicuspid
✕. Severe aortic regurgitation (\>3+)

What they're measuring

Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)

Timeframe: at 1 year post procedure

Trial details

NCT IDNCT06924151

SponsorOsaka University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Koichi Maeda, M.D.

+81 -6-6879-3154 k-maeda@surg1.med.osaka-u.ac.jp

View on ClinicalTrials.gov More Aortic Stenosis trials