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Transcatheter Aortic Valve Replacement System
TAVR for Bicuspid Aortic Valve Disease
N/A
Waitlist Available
Led By Basel Ramlawi, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT
Severe aortic stenosis defined by specific criteria for symptomatic and asymptomatic patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and annually through 10 years
Awards & highlights
Study Summary
This trial is testing a new heart valve to see if it is safe and effective for people with a specific heart condition.
Who is the study for?
This trial is for patients with severe aortic stenosis and bicuspid aortic valve disease who are at low risk for surgical valve replacement. Participants must be over 60, have no major health issues like blood disorders or recent heart attacks, and not be pregnant or breastfeeding. They should agree to follow-up visits.Check my eligibility
What is being tested?
The Medtronic TAVR system is being tested in this study to see if it's safe and effective for people with bicuspid aortic valves needing valve replacement but considered low-risk for traditional surgery.See study design
What are the potential side effects?
Potential side effects may include reactions to materials used in the TAVR system, bleeding complications due to necessary anticoagulation therapy, infection risks, and possible impact on other heart valves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's aortic valve has two flaps and was confirmed by a CT scan.
Select...
I have been diagnosed with severe aortic stenosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year and annually through 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and annually through 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Secondary outcome measures
All Stroke (Disabling and Non-Disabling) Rate
All-Cause Mortality Rate
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
+15 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Medtronic TAVR SystemsExperimental Treatment1 Intervention
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
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Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,182 Total Patients Enrolled
Basel Ramlawi, MDPrincipal InvestigatorParamount Heart
1 Previous Clinical Trials
13 Total Patients Enrolled
Michael Reardon, MDStudy ChairThe Methodist Hospital Research Institute
5 Previous Clinical Trials
4,478 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it unsafe to have a bioprosthetic valve placed.I have severe heart artery blockage.You have severe heart-related shock, ongoing stomach bleeding, refuse to get a blood transfusion, have severe memory loss, or are expected to live less than 2 years.My heart does not have specific conditions that would prevent certain treatments.I am under 60 years old.My heart's aortic valve has two flaps and was confirmed by a CT scan.I am not pregnant, breastfeeding, legally incompetent, or considered vulnerable.I do not have blood disorders, ongoing infections, recent strokes, or artery disease in my neck.I need emergency surgery.My blood vessels are suitable for certain medical procedures.I have been diagnosed with severe aortic stenosis.Your doctor thinks you have a low risk of complications from heart surgery based on a special assessment.I had a heart attack caused by unstable heart arteries within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic TAVR Systems
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the projected results of this experiment?
"This trial is set to span 7 days and will primarily measure the rate of mortality or disabling stroke over that period. Secondary targets are to examine hemodynamic performance metrics such as degree of transvalvular prosthetic regurgitation, total prosthetic valve regurgitation, and myocardial infarction at 30-day post-procedure intervals."
Answered by AI
Are there any unfilled slots remaining in this research trial?
"The clinicaltrials.gov website reveals that this trial, first launched on October 30th 2018, is not presently accepting new patients. However, there are 55 other studies currently recruiting volunteers at the moment."
Answered by AI
What is the geographical spread of this research initiative?
"Currently, 26 different trial sites are accepting participants. Locations include New Haven, Minneapolis and Des Moines along with other locations across the country. Choosing a nearby clinic may reduce your overall travel burden if you join this experimental study."
Answered by AI
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