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Inter-Atrial Shunt Device for Heart Failure
Study Summary
This trial is testing a device to see if it can help reduce pressure in the left atrium for people with heart failure.
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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- I am on dialysis or my kidney function is very low.I am 40 years old or older.I have had a heart attack or heart surgery in the last 3 months.I started heart rhythm treatment within the last 6 months.I have ongoing heart failure symptoms.I have not had a stroke, TIA, DVT, or pulmonary emboli in the last 6 months.I have severe heart failure.I cannot walk 50m in 6 minutes, or I can walk more than 600m.I have a significant blockage in my neck artery that hasn't been treated.Your heart's pumping ability is at least 40%, and it has not been less than 30% in the past.I have a serious heart valve problem.My heart failure treatment and any other health conditions are currently stable.Your left atrial pressure during exercise is too high compared to your right atrial pressure.
- Group 1: Treatment with Inter-Atrial Shunt Device
- Group 2: Control
- 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 applications for this clinical trial still being accepted?
"As per records in clinicaltrials.gov, this medical trial is not presently accepting new patients. It was initially posted on December 1st 2015 and the page was most recently updated on June 20th 2022. Despite no longer being actively recruiting participants, there are 700 other studies that require volunteers at present."
Are there any American medical centers facilitating this trial?
"Eighteen different medical facilities are offering this trial, including locations in Winston-Salem, Rochester and Columbus. To reduce the burden of travel for potential participants, it is recommended to select a clinical site nearest you if enrolling in the study."
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