Atrial Flow Regulator for Heart Failure

(FROST-HF Trial)

Recruiting at 31 trial locations

Overseen By Kelly Aspinwall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Occlutech International AB

Must be taking: Guideline directed medical therapy

Must not be taking: Pulmonary hypertension drugs

Disqualifiers: Recent MI, Stroke, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 months

698 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.

Will I have to stop taking my current medications?

The trial requires participants to be on stable guideline-directed medical therapy (GDMT) for heart failure, so you will likely need to continue your current heart failure medications. The protocol does not specify stopping other medications, but you should discuss your specific situation with the trial team.

What data supports the effectiveness of the Atrial Flow Regulator treatment for heart failure?

The AFR-PRELIEVE trial suggests that using the Atrial Flow Regulator (AFR) to reduce high pressure in the heart's left atrium may be a safe and feasible option for treating heart failure patients, potentially improving their symptoms. ^{1 2 3 4 5}

How does the Atrial Flow Regulator treatment differ from other heart failure treatments?

The Atrial Flow Regulator (AFR) is unique because it involves implanting a device to reduce pressure in the left atrium of the heart, which can help alleviate symptoms in heart failure patients. Unlike traditional drug therapies, this device directly modifies heart function by creating a controlled shunt, potentially improving survival and quality of life without affecting overall heart output. ^{1 2 5 6 7}

Research Team

Megan Coylewright, MD,MPH,FACC

Principal Investigator

Erlanger Health System

Muthiah Vaduganathan, MD, MPH

Principal Investigator

Brigham and Women's Hospital Heart and Vascular Center

Eligibility Criteria

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.

Inclusion Criteria

I have chronic heart failure symptoms that affect my daily activities.

I was hospitalized for heart failure within the last 6 months.

I am 18 years old or older.

Exclusion Criteria

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 need oral steroids or oxygen during the day for my severe COPD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Atrial Flow Regulator device or undergo a sham procedure

12-24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term Follow-up

Participants are monitored for long-term outcomes including cardiovascular mortality and device performance

5 years

Treatment Details

Interventions

• Atrial Flow Regulator
• Sham Comparator

Trial Overview 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.

Participant Groups

Group I: Roll-in Arm Experimental Treatment 1 Intervention

Patients in the Roll-in Arm will receive the AFR device

Group II: Randomization to 6mm AFR device Active Control 1 Intervention

AFR Device 6mm vs Sham procedure

Group III: Randomization to 8mm AFR device Active Control 1 Intervention

AFR device 8mm vs Sham procedure

Group IV: Randomization to sham procedure Placebo Group 1 Intervention

Sham procedure to AFR device (6mm or 8mm)

Who Is Running the Clinical Trial?

Occlutech International AB

Lead Sponsor

Trials

16

Recruited

4,100+

References

1. England pubmed.ncbi.nlm.nih.gov

Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction. [2023]

2. France pubmed.ncbi.nlm.nih.gov

The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Atrial fibrillation and heart failure: natural history and pharmacological treatment. [2007]

4. Germany pubmed.ncbi.nlm.nih.gov

Stroke and Thromboembolism in Patients with Heart Failure and Sinus Rhythm: A Matter of Risk Stratification? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of controlling the heart rate on the heart failure index and on heart function in heart failure patients with atrial fibrillation. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Atrial fibrillation and heart failure comorbidity. [2007]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure. [2022]