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Transcatheter Heart Valve

TAVR for Aortic Stenosis (PII S3i Trial)

N/A

Waitlist Available

Led By Craig Smith, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PII S3i Trial 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.Check my eligibility

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.See study design

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.

PII S3i Trial 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.

PII S3i Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate

Secondary outcome measures

Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days

PII S3i 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

~5790

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

60,500 Total Patients Enrolled

Craig Smith, MDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

3,089 Total Patients Enrolled

Martin B Leon, MDPrincipal InvestigatorColumbia University

11 Previous Clinical Trials

10,064 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial offer admissions to eligible subjects?

"Clinicaltrials.gov affirms that this medical trial, first posted on February 17th 2014, is no longer seeking participants. Nonetheless, there are still 161 other studies actively searching for candidates at the present moment in time."

Answered by AI

How many sites are currently engaging with this clinical trial?

"Currently, 51 sites are recruiting patients for this clinical trial. A few of these locations include Madison, Gainesville and Minneapolis; however there are many more available. To reduce travel demands associated with the study, it is advisable to select a site in close proximity."

Answered by AI

Recent research and studies

European Heart JournalJournal

Low and Elevated B-type Natriuretic Peptide Levels Are Associated with Increased Mortality in Patients with Preserved Ejection Fraction Undergoing Transcatheter Aortic Valve Replacement: An Analysis of the PARTNER II Trial and Registry

Chen, Shmuel, Bjorn Redfors, Brian P O’Neill, Marie-Annick Clavel, Philippe Pibarot, Sammy Elmariah, Tamim Nazif, et al.. 2019. “Low and Elevated B-type Natriuretic Peptide Levels Are Associated with Increased Mortality in Patients with Preserved Ejection Fraction Undergoing Transcatheter Aortic Valve Replacement: An Analysis of the PARTNER II Trial and Registry”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehz892.

Journal of the American Heart AssociationJournal

Atrial Fibrillation Is Associated with Mortality in Intermediate Surgical Risk Patients with Severe Aortic Stenosis: Analyses from the PARTNER 2A and PARTNER S3i Trials

Brener, Michael I., Isaac George, Ioanna Kosmidou, Tamim Nazif, Zixuan Zhang, Jose M. Dizon, Hasan Garan, et al.. 2021. “Atrial Fibrillation Is Associated with Mortality in Intermediate Surgical Risk Patients with Severe Aortic Stenosis: Analyses from the PARTNER 2A and PARTNER S3i Trials”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.120.019584.

Journal of the American College of CardiologyJournal

Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement

Ong, Geraldine, Philippe Pibarot, Bjorn Redfors, Neil J. Weissman, Wael A. Jaber, Raj R. Makkar, Stamatios Lerakis, et al.. 2020. “Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2020.10.032.

CirculationJournal