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Atrial Flow Regulator for Heart Failure (FROST-HF Trial)
FROST-HF Trial Summary
This trialtests a new device to help treat heart failure in adults on stable medical therapy.
FROST-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFROST-HF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FROST-HF Trial Design
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Who is running the clinical trial?
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- I have chronic heart failure symptoms that affect my daily activities.I haven't had a stroke, TIA, DVT, or pulmonary emboli in the last 6 months and don't have any ongoing brain issues.I am currently being treated for pulmonary hypertension with specific medication.I was hospitalized for heart failure within the last 6 months.I need oral steroids or oxygen during the day for my severe COPD.I am 18 years old or older.I can walk between 100 to 450 meters in 6 minutes.I am on dialysis for chronic kidney disease.My heart beats too fast (over 110 bpm) even with medication.I have not had major surgery in the last 3 months.Your right ventricle (part of the heart) is not working properly based on specific tests.You have a medical condition that makes it hard for you to exercise, other than heart failure.I am currently on immunosuppressants or oral steroids.I have a serious heart valve problem.Your NT-proBNP or BNP levels are higher than a certain number.I have a bleeding disorder.I have a history of specific heart muscle or pericardial diseases.My heart's pumping ability is good.I have a serious untreated blockage in my neck artery.Your veins are not suitable for a shunt to be implanted.I have had a heart attack or heart surgery in the last 3 months.I am allergic or cannot take certain medications.My blood pressure is very high despite taking medication.Your heart ultrasound shows a mass, blood clot, or infection.I have heart artery blockage that hasn't been treated yet.I have had surgery or a procedure to close a hole in my heart.I started resynchronization therapy less than 3 months ago.I've been on the highest safe doses of heart failure medications and devices for at least 2 months.I had heart valve surgery or a procedure through a catheter within the last 2 months.I had an AICD placed less than 2 months ago.
- Group 1: Randomization to 6mm AFR device
- Group 2: Roll-in Arm
- Group 3: Randomization to 8mm AFR device
- Group 4: Randomization to sham procedure
- 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 any current opportunities for individuals to join this clinical experimentation?
"Indeed, the clinicaltrials.gov database has information which confirms that this medical trial is currently seeking applicants. It was first posted on November 1st 2022 and last edited on the 8th of the same month; moreover, a total of 698 patients need to be recruited from 4 different locations."
What is the primary objective of this investigation?
"This upcoming medical study seeks to measure the Composite Primary Efficacy Endpoint with a 12-month timeline. Additionally, Secondary objectives include Clinical performance change from Baseline assessed by NYHA Classification, EQ-5D, and 6 Minute Walk Test (MWT)."
How many medical sites are hosting the clinical trial?
"The current roster of medical centers offering this clinical trial includes Medstar in Washington, University of Mississippi Medical Center in Jackson, and Erlanger Health System in Chattanooga. There are 4 other sites available as well."
What is the maximum capacity for participation in this research project?
"Occlutech International AB will be carrying out the experiment in multiple locations, such as Medstar situated in Washington D.C and University of Mississippi Medical Centre located in Jackson, MS. The trial necessitates 698 individuals that meet its inclusion criteria for participants to take place successfully."
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