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Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOsaka University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR

AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90 days prior to randomization

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • surgical aortic valve replacement

    Procedure/Surgery

    SAVR

  • Transcatheter aortic valve replacement

    Procedure/Surgery

    TAVR

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Surgical aortic valve replacementExperimental treatment 1 intervention
Group B: Transcatheter aortic valve replacementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at 1 year post procedure

Secondary outcomes

1

the rate of all-cause mortality or disabling stroke

Time frame
at one year
2

the rate of all-cause mortality

Time frame
at one year
3

the rate of all stroke

Time frame
at one year
4

the rate of disabling stroke

Time frame
at one year

Other outcomes

1

All cause mortality

Time frame
at 30 days
2

The rate of all stroke (disabling and nondisabling)

Time frame
at 30 days
3

The rate of Rehospitalization (valve-related or procedure-related and including heart failure)

Time frame
at 30 days
4

All cause mortality or all stroke

Time frame
at one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Osaka University

Lead sponsor

Source ClinicalTrials.gov
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