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Transcatheter Atrial Shunt for Heart Failure (ALt FLOW US Trial)
ALt FLOW US Trial Summary
This trial will test a new device to treat heart failure. The device will be inserted in the heart to help it pump better.
ALt FLOW US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowALt FLOW US Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ALt FLOW US Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with chronic heart failure.My heart has significant valve issues, confirmed by a cardiologist.My body or any device in it is not suitable for the Edwards heart shunt system.You are currently using recreational drugs through injection.My kidneys are not working properly.I cannot take certain blood thinners or have a bleeding disorder.I am under legal guardianship.I have had a stroke, TIA, or started cardiac therapy in the last 6 months.I have not had unstable blood pressure or heart issues in the last 30 days.I had a heart attack or heart procedure in the last 3 months.I have not had endocarditis or any infection in the last 3 months.You are allergic to medications that prevent blood clots or to contrast agents used for imaging, and this allergy cannot be treated.I am on a stable treatment plan for heart failure.Your pulmonary vascular resistance at rest falls between 3.0 and 8.0 Wood Units.I do not have severe heart failure.I have been diagnosed with a specific type of heart muscle disease.I can walk less than 50 meters or more than 600 meters in 6 minutes.My heart's right side is not working properly.You are a woman who could become pregnant and have a positive pregnancy test, or you are breastfeeding, or planning to become pregnant during the trial.Your average pulmonary artery pressure at rest is 25 mmHg or higher.My pulmonary hypertension improved with a specific test.I had heart valve surgery or a procedure without open surgery within the required time frame.I am 18 years old or older.You have a known allergy to nickel or tantalum.The doctor thinks you may have less than a year to live for reasons not related to the heart.My heart's right side is not working properly.You have high blood pressure during rest or during a stress test while lying down.You have a condition where blood flow is redirected in a way that affects your health, as determined by the doctor.My liver is not working well.
- Group 1: Edwards Transcatheter Atrial Shunt System
- 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 have volunteered to partake in this research?
"That is correct. The clinicaltrials.gov website lists this medical study as actively recruiting participants since its initial posting on July 31st, 2018 and most recently being updated in January 25th 2022. A total of 55 patients must be enrolled across 11 different sites."
Are enrollment slots still available for this medical experiment?
"Data on clinicaltrials.gov suggests that this medical trial is actively recruiting volunteers, with its first posting occurring on July 31st 2018 and most recent revision made January 25th 2022."
How many healthcare facilities are hosting this investigation?
"This clinical trial is being conducted at Montefiore Medical Center (Bronx, NY), UC San Diego Health (La Jolla, CA) and University of Kansas (Kansas City, KS). Additionally 11 other sites are participating."
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