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Device
Atrial Flow Regulator for Heart Failure (FROST-HF Trial)
N/A
Waitlist Available
Led By Muthiah Vaduganathan, MD, MPH
Research Sponsored by Occlutech International AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of chronic symptomatic HF (NYHA ≥class 2) and at least one of the following:
Aged ≥18 years
Must not have
History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months prior to informed consent, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding
Prior diagnosis of pulmonary hypertension with current treatment with one or more pulmonary hypertension specific drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through end of study, approximately 5 years
Summary
This trialtests a new device to help treat heart failure in adults on stable medical therapy.
Who is the study for?
Adults over 18 with chronic heart failure who are on stable heart medication can join. They must have been hospitalized for heart failure or have certain levels of NT-proBNP/BNP, and a specific walking test result. Excluded are those with recent heart attacks, surgeries, uncontrolled conditions like atrial fibrillation or hypertension, bleeding disorders, severe lung disease, kidney issues requiring dialysis, and other specific cardiovascular problems.
What is being tested?
The trial is testing the Atrial Flow Regulator against a sham procedure to see if it's safe and effective for treating symptomatic heart failure in patients already following standard medical guidelines. Participants will be randomly assigned to either receive the device or undergo a fake procedure without knowing which one they got.
What are the potential side effects?
Potential side effects may include complications from the implantation procedure such as bleeding or infection at the site of insertion, irregular heartbeat due to the device presence in the heart chamber, blood clots that could lead to stroke or other issues related to device compatibility with individual patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic heart failure symptoms that affect my daily activities.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a stroke, TIA, DVT, or pulmonary emboli in the last 6 months and don't have any ongoing brain issues.
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I am currently being treated for pulmonary hypertension with specific medication.
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I need oral steroids or oxygen during the day for my severe COPD.
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I am on dialysis for chronic kidney disease.
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My heart beats too fast (over 110 bpm) even with medication.
Select...
I am currently on immunosuppressants or oral steroids.
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I have a serious heart valve problem.
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I have a bleeding disorder.
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I have a history of specific heart muscle or pericardial diseases.
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I have a serious untreated blockage in my neck artery.
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I am allergic or cannot take certain medications.
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My blood pressure is very high despite taking medication.
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I have heart artery blockage that hasn't been treated yet.
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I have had surgery or a procedure to close a hole in my heart.
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I had heart valve surgery or a procedure through a catheter within the last 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ implant through end of study, approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant through end of study, approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Primary Efficacy Endpoint - Frequency of Cardiovascular Mortality
Composite Primary Efficacy Endpoint - Frequency of heart transplant or Left Ventricular Assist Device (LVAD)
Composite Primary Efficacy Endpoint - KCCQ Score
+3 moreSecondary study objectives
Clinical performance - change from baseline in NYHA Classification
Clinical performance - change from baseline using EQ-5D
Clinical performance - change from baseline using KCCQ
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Roll-in ArmExperimental Treatment1 Intervention
Patients in the Roll-in Arm will receive the AFR device
Group II: Randomization to 6mm AFR deviceActive Control1 Intervention
AFR Device 6mm vs Sham procedure
Group III: Randomization to 8mm AFR deviceActive Control1 Intervention
AFR device 8mm vs Sham procedure
Group IV: Randomization to sham procedurePlacebo Group1 Intervention
Sham procedure to AFR device (6mm or 8mm)
Find a Location
Who is running the clinical trial?
Occlutech International ABLead Sponsor
15 Previous Clinical Trials
3,355 Total Patients Enrolled
2 Trials studying Heart Failure
256 Patients Enrolled for Heart Failure
Muthiah Vaduganathan, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital Heart and Vascular Center
Megan Coylewright, MD, MPH, FSCAI, FACCPrincipal InvestigatorErlanger Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.