Atrial Flow Regulator for Heart Failure

(FROST-HF Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a device called the Atrial Flow Regulator for people with heart failure. Heart failure occurs when the heart doesn't pump blood efficiently. The study targets individuals with either preserved or reduced ejection fraction, two types of heart failure. Participants will either receive the device or undergo a procedure that mimics receiving it to evaluate its effectiveness. Those with ongoing heart failure symptoms, such as difficulty with daily activities or frequent hospital visits for heart issues, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could enhance heart failure treatments.

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 prior data suggests that the Atrial Flow Regulator is safe for heart failure patients?

Research has shown that the Atrial Flow Regulator (AFR) is generally safe for people with heart failure. In one study, researchers tested the AFR on patients with various heart conditions. The results indicated that the device was safe and feasible, regardless of the patient's heart function level. Another study found that the long-term risk of death after using the AFR was low, at about 1.9%, suggesting the device is quite safe for heart failure patients. Additionally, the AFR has been successfully used in both children and adults, improving heart function and symptoms. Overall, these studies suggest that the AFR is well-tolerated and has a good safety record for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Atrial Flow Regulator (AFR) is unique because it represents a novel approach to managing heart failure by mechanically optimizing blood flow between the atria. Unlike conventional treatments like medications or lifestyle changes that primarily aim to reduce symptoms and slow disease progression, the AFR device physically alters the heart's structure to improve its function. Researchers are excited about this treatment because it offers a new, minimally invasive way to potentially enhance cardiac output and quality of life for patients with heart failure, beyond what current pharmacological therapies can achieve. Additionally, the AFR comes in different sizes (6mm and 8mm), allowing for more personalized treatment based on individual patient needs.

What evidence suggests that the Atrial Flow Regulator is effective for heart failure?

This trial will evaluate the Atrial Flow Regulator (AFR) device for heart failure. Research has shown that the AFR device can help people with heart failure by lowering heart pressure. Studies have found that this device is safe and can improve heart function and symptoms for many patients. In one study, the AFR reduced high pressure in the heart, a common issue in heart failure. This improvement can lead to better survival rates and fewer heart-related problems. Overall, the AFR device seems promising in helping people with heart failure feel better and possibly live longer. Participants in this trial may receive either the AFR device or a sham procedure for comparison. ^{5 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 can walk between 100 to 450 meters in 6 minutes.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10375067/

Predicted impact of atrial flow regulator on survival in heart ... We aim to assess the theoretical impact of the atrial flow regulator (AFR) on survival in heart failure.

2. eurointervention.pcronline.com eurointervention.pcronline.com/article/the-afr-prelieve-trial-a-prospective-non-randomized-pilot-study-to-assess-the-atrial-flow-regulator-afr-in-heart-failure-patients-with-either-preserved-or-reduced-ejection-fraction

The AFR-PRELIEVE trial: a prospective, non-randomised ... This pilot study evaluated the safety and feasibility of the Atrial Flow Regulator device in reducing elevated left atrial pressure in 36 symptomatic heart ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772930323012115

Feasibility, Safety, and Efficacy of the Atrial Flow Regulator ... AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04334694

NCT04334694 | Atrial Flow Regulator in Heart Failure There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7522821/

The atrial flow regulator: current overview on technique and ... Invasive measurement of LAP, guiding medical therapy in patients with HFrEF, was associated with improved symptoms and a reduction of early clinical events.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37312287/

Predicted impact of atrial flow regulator on survival in heart ... Conclusions: In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate. Dedicated randomised, controlled ...

7. academic.oup.com academic.oup.com/eurheartj/article/44/Supplement_2/ehad655.1060/7392024

PRELIEVE trial:Final 1-year outcomes of the prospective atrial ... Implantation of AFR device with either 8 or 10 mm shunt size in HF patients was safe and feasible irrespective of baseline ejection fraction.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0146280625001021

Safety and effectiveness after atrial shunt device in patients ... The long-term estimated pooled mortality of ASD in heart failure patients was 1.9% (95% CI: 0.1% to 3.8%), indicating it is a relatively safe option.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307382/

Feasibility, Safety, and Efficacy of the Atrial Flow Regulator in ... AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.