Health TrialsbyHealthPanel

PARTNER 3 Trial - Aortic Valve-in-Valve

ConditionsAortic StenosisAortic Stenosis, Severe
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences

About this trial

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.

NYHA Functional Class ≥ II.

Heart Team agrees the patient is low to intermediate risk.

Disqualifiers

Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)

Severe regurgitation (> 3+) or stenosis of any other valve

Failing valve has moderate or severe paravalvular regurgitation

Failing valve is unstable, rocking, or not structurally intact

Trial design

Design model

Single group

Treatments tested in this trial

  • Edwards SAPIEN 3/SAPIEN 3 Ultra THV

    Device

    Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: TAVR - Failing surgical or transcatheter valveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke

Number of patients that died and/or had a stroke

Time frame
1 year

Secondary outcomes

1

Mean gradient

Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.

Time frame
30 days
2

Peak gradient

Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.

Time frame
30 days
3

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.

Time frame
30 days
4

New York Heart Association (NYHA) Classification

Change from baseline in NYHA. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.

Time frame
30 days

Other outcomes

Sponsors and contacts

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

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
Apply now