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PCI vs Medical Management for Aortic Stenosis (COMPLETE TAVR Trial)
COMPLETE TAVR Trial Summary
This trial will compare the outcomes of two different strategies for managing concomitant CAD in patients undergoing TAVR: complete revascularization vs. medical therapy alone.
COMPLETE TAVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMPLETE TAVR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMPLETE TAVR Trial Design
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Who is running the clinical trial?
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- I had or will have a PCI procedure close to my TAVR surgery date.I am scheduled for a procedure to open blocked arteries in my heart.You have something that would prevent you from being followed up for 5 years.My heart team agrees I can have a specific heart valve replacement through my thigh and would get a bypass if I had surgery.I do not have unstable blood pressure or breathing problems.I had a successful heart valve replacement via catheter within the last 4 days without major issues.I have a significant blockage in one of my heart's arteries that can be treated without surgery.I have not had a stroke or mini-stroke in the last 3 months.My heart's arteries start unusually high, increasing my risk of blockage.My heart's left ventricle is functioning poorly.I am scheduled for surgery to improve blood flow to my heart.I have had heart bypass or valve replacement surgery.My kidney function is very low or I am on dialysis.I have not had a heart attack in the last 90 days.I have severe aortic valve stenosis with significant symptoms or test results.I have a health condition that is not heart-related and is expected to shorten my life to under 5 years.You have a serious problem with the mitral valve in your heart.
- Group 1: Complete Revascularization
- Group 2: Medical Therapy Alone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities for prospective participants to take part in this clinical investigation?
"Affirmative. According to the clinicaltrials.gov portal, this experiment is currently recruiting volunteers. It was first advertised on December 19th of 2020 and most recently updated on March 31st 2022 with a goal to secure 4000 participants from 26 separate locations."
To what extent is the recruitment process for this clinical trial progressing?
"Affirmative, according to clinicaltrials.gov's database this research is actively recruiting. This investigation was initially posted on December 19th 2020 and has been recently modified on March 31st 2022. 4000 patients are necessary for the trial at 26 centers across the country."
Where are the primary venues of this clinical experiment?
"This clinical trial has recruited participants from a total of 26 sites, such as St. Joseph Mercy Health System in Ypsilanti, University of Minnesota Medical Center in Minneapolis, and Parkview Research Center in Fort Wayne."
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