Health TrialsbyHealthPanel

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

ConditionsAortic Stenosis, CalcificAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEdwards Lifesciences

About this trial

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65 years of age or older at time of randomization

Moderate aortic stenosis

Subject has symptoms or evidence of cardiac damage/dysfunction

The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Disqualifiers

Native aortic annulus size unsuitable for the THV

Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system

Aortic valve is unicuspid or non-calcified

Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

    Device

    Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Treatment groups

2,250 Participants
are divided into 2 treatment groups
Group A: TAVRExperimental treatment 1 intervention
Group B: CSNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary Effectiveness Endpoint

Non-hierarchical composite of death, and heart failure hospitalization or event

Time frame
2 years
2

Primary Safety Endpoint

Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention

Time frame
30 days

Secondary outcomes

1

Death, stroke, or heart failure hospitalization

The number of patients that had this event

Time frame
2 years
2

Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years

The number of patients that met all these criteria

Time frame
2 years
3

Heart failure hospitalization

The number of patients that had this event

Time frame
2 years
4

Left ventricle (LV) mass index

Echocardiographic measurement of the size of the left ventricle

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
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