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TAVR for Heart Failure
Study Summary
This trial is testing whether TAVR is safe and effective for heart failure patients with moderate aortic stenosis, as compared to those who receive no treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My heart's right ventricle is not working well.I am allergic or cannot take clopidogrel, aspirin, or blood thinners if needed.I am a woman who could become pregnant.You have other conditions that make it difficult for you to understand and follow the study requirements.My doctor expects I have less than 2 years to live because of my cancer or other chronic illness.I was born with a one or two-leaf aortic valve.I do not have an active infection, including heart infection.I am not willing to receive blood transfusions.You are allergic to contrast dye and cannot be properly treated before using it.You have been diagnosed with moderate aortic stenosis (AS) by a specialized medical imaging center.Your heart's pumping ability at rest is less than 50%.I had a heart artery procedure within the last month.I am 18 years old or older.My heart condition limits my physical activities.I have been on stable heart failure treatment for at least 1 month.I have been advised to undergo surgery for a heart valve problem not involving the aorta.I have had a stroke that left me with some lasting disabilities.My kidney function is very low or I am on dialysis.My liver condition is severe (Child-Pugh C).I am not willing to undergo follow-up tests.I had a CRT device implanted within the last month.I have severe leakage in my heart valves.I was hospitalized for worsening heart failure within the last 2 weeks.You do not have enough calcification on your aortic valve for a specific type of heart procedure.I show signs of memory loss or confusion.My heart's pumping ability is very weak.You have had surgery to replace your aortic valve with a mechanical or bioprosthetic valve in the past.I have severe lung disease or need daily oxygen support.My body is suitable for a specific heart valve replacement through my thigh.There is a growth or clot in your heart.I have not had any GI bleeding in the last 3 months.
- Group 1: TAVR (with SAPIEN 3 THV) and OHFT
- Group 2: OHFT
- 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
What is the aggregate tally of participants in this trial?
"To properly execute this study, Avania must find 300 volunteers meeting the inclusion criteria. The sponsor has decided to run clinical operations out of UCLA Medical Center in Los Angeles, Wisconsin and Advocate Aurora- St. Lukes in Milwaukee, Maine."
What is the geographic reach of this clinical experiment?
"To date, 47 patients have been enrolled in this trial at various locations such as UCLA Medical Center (Los Angeles), Advocate Aurora-St. Lukes (Milwaukee) and Maine Medical Centre (Portland). In addition to these sites, there are 44 other enrolment points across the US."
Are there still openings in this experiment that participants can take advantage of?
"Affirmative. According to the details posted on clinicaltrials.gov, this medical trial is now selecting participants and was first made public on September 1st 2016. The study requires 300 individuals from 47 different sites across the US."
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