150 Participants NeededMy employer runs this trial

SAPIEN 3 Ultra RESILIA Valve for Aortic Valve Stenosis

Recruiting at 1 trial location
JR
EP
Overseen ByEmilie Pelletier beaumont, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

Who Is on the Research Team?

EP

Emilie Pelletier beaumont, MSc

Principal Investigator

Fondation IUCPQ

JR

Josep Rodés-Cabau, MD

Principal Investigator

IUCPQ-UL

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had a SAPIEN 3 Ultra RESILIA valve successfully implanted.
The medical device was successfully placed and removed in my procedure.
I am getting a TAVR with the SAPIEN 3 Ultra RESILIA valve for severe aortic stenosis.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo TAVR with the SAPIEN 3 Ultra RESILIA valve

Procedure day
1 visit (in-person)

Initial Follow-up

Clinical and echocardiographic follow-up to assess primary outcomes

1-3 months
1 visit (in-person)

Long-term Follow-up

Participants are monitored for valve performance and clinical events

Up to 10 years
Yearly visits (in-person)

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials
26
Recruited
6,300+