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Transcatheter Aortic Valve Replacement (TAVR)
TAVR for Aortic Stenosis
N/A
Recruiting
Led By Paul Sorajja, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate AS, defined by transthoracic echo (TTE) as assessed by the ECL: AVA >1.0 cm² and < 1.5 cm² and Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg
Symptoms of AS, defined as NYHA ≥ Class II, or Reduced functional capacity, defined as 6MWT < 300 meters, or < 85% of age-sex predicted METs on exercise tolerance testing (ETT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether the Medtronic TAVR System is safe and effective for patients with moderate, symptomatic aortic stenosis.
Who is the study for?
This trial is for adults over 65 with moderate, symptomatic aortic stenosis (AS) who have specific heart function measurements and are suitable for the Medtronic TAVR System via transfemoral access. Excluded are those needing cardiac surgery, with certain types of bicuspid aortic valves or severe heart issues like low ejection fraction or cardiac amyloidosis.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of two Medtronic TAVR systems in expanding treatment to patients with moderate AS. Participants will receive either the Evolut PRO+ or FX system along with standard heart management therapies.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from procedures like TAVR can include bleeding, blood vessel complications, irregular heartbeats, stroke, kidney injury, and sometimes death.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve is moderately narrowed.
Select...
I have symptoms of aortic stenosis or my physical ability is below normal levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Secondary outcome measures
All-cause mortality
Composite of all-cause mortality and heart failure hospitalizations or events.
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)Experimental Treatment1 Intervention
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
Group II: Clinical site determined guideline-directed management and therapy (GDMT) aloneActive Control1 Intervention
Clinical site determined guideline-directed management and therapy (GDMT) alone
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,668 Total Patients Enrolled
22 Trials studying Aortic Valve Stenosis
14,966 Patients Enrolled for Aortic Valve Stenosis
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
472 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
11 Patients Enrolled for Aortic Valve Stenosis
Josep Rodes-Cabau, MDPrincipal InvestigatorFondation IUCPQ
6 Previous Clinical Trials
691 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
11 Patients Enrolled for Aortic Valve Stenosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cardiac amyloidosis.I need and am a candidate for a procedure to improve blood flow to my heart.Your heart's pumping ability is very weak, as shown by a heart ultrasound test.I have symptoms of aortic stenosis or my physical ability is below normal levels.My heart valve is moderately narrowed.You have had a heart failure event or hospitalization within the past year, certain heart-related test results are abnormal, or you have specific heart conditions that make you unsuitable for the study.My body is not suitable for a specific heart valve replacement through the leg.I need heart surgery as recommended by my doctor.I am younger than 65 years old.My aortic valve is abnormal, either Type 0, Type 2, or Type 1 with a large ascending aorta.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
- Group 2: Clinical site determined guideline-directed management and therapy (GDMT) alone
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.
Is the enrollment window for this research still open?
"As of now, this clinical trial is actively seeking qualified participants. It was initially listed on April 27th 2022 and the latest update to its profile was made on November 21st 2022."
Answered by AI
How many individuals can be enrolled in this clinical research?
"Medtronic Cardiovascular, the trial's sponsor, is responsible for recruiting 650 suitable patients from sites such as Erlanger Medical Center in Chattanooga, Tennessee and Abrazo Arizone Heart Hospital in Phoenix, Arizona."
Answered by AI
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