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Transcatheter Heart Valve

TAVR for Aortic Stenosis (PII S3i Trial)

N/A
Waitlist Available
Led By Martin B Leon, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
Be older than 18 years old
Must not have
Heart team assessment of inoperability (including examining cardiac surgeon).
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart valve and delivery system for people with aortic stenosis. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for patients with severe, symptomatic aortic stenosis who are at intermediate risk. They must have heart valve issues confirmed by specific tests and be able to follow up for five years post-procedure. It's not suitable for those deemed inoperable, unstable, needing emergency surgery, or with complex coronary artery disease.
What is being tested?
The PARTNER II Trial is testing the Edwards SAPIEN 3 transcatheter heart valve in patients with calcific aortic stenosis. The goal is to assess its safety and effectiveness compared to standard treatments in individuals at intermediate surgical risk.
What are the potential side effects?
Possible side effects of TAVR include bleeding, blood vessel complications, irregular heartbeats, stroke, infection around the valve implant site and potential need for a permanent pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have symptoms from a heart valve problem and it affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
A team of heart specialists has determined I cannot have heart surgery.
Select...
I haven't needed heart or lung support machines in the last 30 days.
Select...
I require emergency surgery.
Select...
My left main coronary artery is unprotected.
Select...
I have complex heart artery disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PIIS3i - SAPIEN 3Experimental Treatment1 Intervention
PIIS3i - SAPIEN 3 is Operable Group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVR
2017
N/A
~6010

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,034 Total Patients Enrolled
Martin B Leon, MDPrincipal InvestigatorColumbia University
11 Previous Clinical Trials
10,064 Total Patients Enrolled
Craig Smith, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
3,089 Total Patients Enrolled

Media Library

Edwards SAPIEN 3 (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT03222128 — N/A
Aortic Stenosis Research Study Groups: PIIS3i - SAPIEN 3
Aortic Stenosis Clinical Trial 2023: Edwards SAPIEN 3 Highlights & Side Effects. Trial Name: NCT03222128 — N/A
Edwards SAPIEN 3 (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03222128 — N/A
~91 spots leftby Dec 2025
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