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Prosthetic Valve

Prospective TAVR Arm for Aortic Stenosis

Q: Are there numerous facilities conducting this investigation within the US?

<p>WellStar Kennestone Hospital in Marietta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>, VCU Medical Center in Richmond, <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a> and Henrico Doctors' Hospital in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> D.C are just some of the medical centers that are enrolling patients for this trial. An additional 11 locations have also been identified to participate.</p>

N/A

Waitlist Available

Research Sponsored by Megan Rowland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 6 months, 12 months, and 2,3,4 and 5 years

Awards & highlights

Study Summary

This trial assesses the safety and feasibility of a less invasive heart valve replacement surgery for people with a specific heart condition.

Eligible Conditions

Aortic Stenosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 6 months, 12 months, and 2,3,4 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 6 months, 12 months, and 2,3,4 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 6 months, 12 months, and 2,3,4 and 5 years 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 Mortality

All Stroke (disabling and non-disabling, ischemic and hemorrhagic

All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

+4 more

Secondary outcome measures

VARC - 2 Device Success

composite of all-cause mortality, stroke, spontaneous MI, re-intervention

Trial Design

3Treatment groups

Experimental Treatment

Group I: Prospective TAVR ArmExperimental Treatment1 Intervention

200 patients prospectively undergoing transfemoral TAVR

Group II: Low-Risk TAVR with Bicuspid Aortic ValveExperimental Treatment1 Intervention

The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.

Group III: Historical SAVR ControlsExperimental Treatment1 Intervention

Historical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transfemoral TAVR

2016

N/A

~300

SAVR

2016

N/A

~740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Megan RowlandLead Sponsor

Medstar Health Research InstituteLead Sponsor

189 Previous Clinical Trials

115,273 Total Patients Enrolled

Frequently Asked Questions

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

Are there numerous facilities conducting this investigation within the US?

"WellStar Kennestone Hospital in Marietta, Georgia, VCU Medical Center in Richmond, Virginia and Henrico Doctors' Hospital in Washington D.C are just some of the medical centers that are enrolling patients for this trial. An additional 11 locations have also been identified to participate."

Answered by AI

Are there any available openings to participate in this clinical trial?

"Clinicaltrials.gov states that this trial is not presently actively recruiting patients, although it was first posted on January 1st 2016 and updated to its latest version back in March of 2022. That being said, there are currently 307 other medical trials looking for participants at the moment."

Answered by AI

Recent research and studies

American Heart JournalJournal

Feasibility of Transcatheter Aortic Valve Replacement in Low-risk Patients with Symptomatic Severe Aortic Stenosis: Rationale and Design of the Low Risk TAVR (LRT) Study

Rogers, Toby, Rebecca Torguson, Roshni Bastian, Paul Corso, and Ron Waksman. 2017. “Feasibility of Transcatheter Aortic Valve Replacement in Low-risk Patients with Symptomatic Severe Aortic Stenosis: Rationale and Design of the Low Risk TAVR (LRT) Study”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2017.03.008.

The American Journal of CardiologyJournal

Coronary Artery Disease Assessed by Computed Tomography-based Leaman Score in Patients with Low-risk Transcatheter Aortic Valve Implantation

Ozaki, Yuichi, Hector M. Garcia-Garcia, Toby Rogers, Rebecca Torguson, Paige E. Craig, Alexandre Hideo-Kajita, Paul Gordon, et al.. 2020. “Coronary Artery Disease Assessed by Computed Tomography-based Leaman Score in Patients with Low-risk Transcatheter Aortic Valve Implantation”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2020.01.022.

Cardiovascular Revascularization MedicineJournal

Balloon-expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-risk Patients with Bicuspid Versus Tricuspid Aortic Stenosis

Medranda, Giorgio A., Toby Rogers, Brian J. Forrestal, Brian C. Case, Charan Yerasi, Chava Chezar-Azerrad, Christian C. Shults, et al.. 2021. “Balloon-expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-risk Patients with Bicuspid Versus Tricuspid Aortic Stenosis”. Cardiovascular Revascularization Medicine. Elsevier BV. doi:10.1016/j.carrev.2021.03.027.

Journal of the American College of CardiologyJournal