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Transcatheter Aortic Valve Replacement (TAVR)

TAVR with CENTERA THV for Aortic Stenosis

N/A
Waitlist Available
Led By Martin 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
Severe, calcific AS
Judged by the Heart Team to be at intermediate risk for open surgical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with severe aortic valve stenosis who are at intermediate risk for surgical aortic valve replacement (SAVR).

Who is the study for?
This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for surgery. Participants must have symptoms and be in NYHA functional class ≥ II. They cannot join if they have certain heart conditions, recent heart attacks or strokes, severe lung disease, kidney failure, bleeding disorders, or an allergy to Nitinol.Check my eligibility
What is being tested?
The study tests the Edwards CENTERA Transcatheter Heart Valve System's safety and performance in those with symptomatic aortic stenosis deemed intermediate risk for surgical replacement. It involves replacing the diseased valve through a less invasive procedure than open-heart surgery.See study design
What are the potential side effects?
Potential side effects may include risks associated with catheter-based procedures such as blood vessel complications, bleeding, irregular heartbeats, stroke, infection around the valve implant site and possible need for permanent pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe, calcified aortic stenosis.
Select...
My heart team considers me at intermediate risk for open heart surgery.

Timeline

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
All-cause Death

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
179 Previous Clinical Trials
61,345 Total Patients Enrolled
61 Trials studying Aortic Valve Stenosis
31,684 Patients Enrolled for Aortic Valve Stenosis
Martin Leon, MDPrincipal InvestigatorColumbia University Medical Center/ NYPH
3 Previous Clinical Trials
2,356 Total Patients Enrolled

Media Library

CENTERA THV (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT03517436 — N/A
Aortic Valve Stenosis Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis Clinical Trial 2023: CENTERA THV Highlights & Side Effects. Trial Name: NCT03517436 — N/A
CENTERA THV (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517436 — N/A

Frequently Asked Questions

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

How many medical facilities are offering the opportunity to participate in this trial?

"This clinical trial is presently enrolling from 23 distinct medical centres. These locations range from Boston to Kansas City while also featuring sites in Washington and beyond. To reduce travel burden, it is important to select the location closest to you when participating."

Answered by AI

Are there any opportunities currently open to participate in the experiment?

"The trial, which was initially posted on September 18th 2018 and last modified October 7th 2022, is not enrolling patients at this time. However, 307 other medical trials are currently accepting participants."

Answered by AI
~16 spots leftby Apr 2025