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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 below
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My heart valve is moderately narrowed.
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I have symptoms of aortic stenosis or my physical ability is below normal levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
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 more

Trial 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
35,682 Total Patients Enrolled
22 Trials studying Aortic Valve Stenosis
14,980 Patients Enrolled for Aortic Valve Stenosis
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
594 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

Evolut FX TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT05149755 — N/A
Aortic Valve Stenosis Research Study Groups: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT), Clinical site determined guideline-directed management and therapy (GDMT) alone
Aortic Valve Stenosis Clinical Trial 2023: Evolut FX TAVR System Highlights & Side Effects. Trial Name: NCT05149755 — N/A
Evolut FX TAVR System (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05149755 — N/A

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

At what number of venues can this research be accessed?

"Erlanger Medical Center in Chattanooga, Tennessee, Abrazo Arizone Heart Hospital in Phoenix, Arizona and Terrebonne General Medical Center in Houma, Louisiana are amongst 11 other clinical trial sites taking part."

Answered by AI
~303 spots leftby Feb 2026