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PROGRESS Trial Summary
This trial is testing a new heart valve to see if it is safe and effective for people with aortic stenosis.
- Aortic Valve Stenosis
- Calcific Aortic Stenosis
PROGRESS Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowPROGRESS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
PROGRESS Trial Design
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Who is running the clinical trial?
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- Your aortic valve is not the right size for the replacement valve.Your body's shape or structure would make it unsafe to place a tube in your leg or safely insert a medical device.You have a specific type of aortic valve or it does not have calcium buildup.You have a specific heart valve condition with a large bulge in the main artery or severe calcification of the valve.Your heart's pumping capacity is less than 20%.You have a type of heart condition that could make a certain heart procedure risky for you.You have a mass, clot, or growth in your heart that can be seen on a heart scan.You have a heart valve shape that could block your heart arteries after a specific heart procedure.You are 65 years old or older when the study starts.You have moderate aortic stenosis.You have signs of heart damage or problems with how your heart works.You already have an artificial or mechanical aortic valve.You have a serious problem with the valve in your heart called aortic regurgitation.You have previously had a balloon aortic valvuloplasty to treat severe aortic stenosis.
- Group 1: TAVR
- Group 2: CS
- 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
How many individuals are enrolled in the study at present?
"Affirmative. Clinicaltrials.gov contains evidence confirming that the clinical trial is actively enrolling participants, with its original posting date of October 12th 2021 and latest update on November 17th 2022. There are 50 sites recruiting a total of 750 patients for this research study."
What is the ultimate outcome being sought from this trial?
"According to the sponsor, Edwards Lifesciences, this two year study aims to measure a composite of death, stroke and unplanned cardiovascular, stroke and unplanned cardiovascular hospitalization. Secondary outcomes that will be observed include mortality rate, decrease in Kansas City Cardiomyopathy Questionnaire score, stroke volume index and frequency of unplanned cardiac admissions."
Is this research currently looking for participants?
"That is correct. According to the clinicaltrials.gov data, this research trial began recruiting on October 12th 2021 and was recently updated November 17th 2022. It seeks 750 participants at 50 different sites around the country."
Are there numerous locations conducting this experiment?
"This study is currently recruiting from a variety of locations, such as New York University Langone Medical Center in New York City, Sentara Norfolk General Hospital in Norfolk and Eisenhower Desert Cardiologys New York University Langone Medical Center in New York City, Sentara Norfolk General Hospital in Norfolk and Eisenhower Desert Cardiology Center located in Rancho Mirage. Additionally there are 50 other sites that have been selected for this trial."
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