PeriCut Catheter System for Heart Failure

(REIMAGINE-HF Trial)

Overseen By Mark Strong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Heart Failure Solutions, Inc.

Must be taking: Diuretics

Must not be taking: Colchicine

Disqualifiers: Recent heart failure hospitalization, others

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the PeriCut Catheter System to determine its safety and effectiveness for a specific type of heart failure. The focus is on heart failure where the heart pumps normally but struggles to relax, making breathing difficult. Participants should have experienced serious breathing trouble due to heart failure, not from other conditions like lung disease. The trial aims to perform a minimally invasive procedure to assess whether this device can improve symptoms. Those who can walk and complete a basic exercise test might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance heart failure treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PeriCut Catheter System is safe for heart failure patients?

Researchers are investigating whether the PeriCut Catheter System can be safely used in people with heart failure. Early results suggest that most patients tolerate the side effects. Tests are assessing whether this system causes any major problems with the heart, brain, or kidneys. Serious issues have not been common so far.

This is an early feasibility study, indicating that the treatment is still in the initial stages of testing for safety and effectiveness. The primary goal is to determine if the procedure can be performed safely and if patients can tolerate it well. Further research will clarify the long-term safety of this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PeriCut Catheter System for heart failure because it offers a minimally invasive approach to treating this condition. Unlike standard treatments that often involve medication or more invasive surgeries, this system uses a catheter to perform a pericardiotomy under fluoroscopic guidance and general anesthesia. This method could potentially reduce recovery time and lower the risk associated with more invasive procedures, making it a promising alternative for patients with heart failure.

What evidence suggests that the PeriCut Catheter System is effective for heart failure?

Research has shown that the PeriCut Catheter System offers a new treatment for a type of heart failure where the heart pumps normally but remains stiff, leading to complications. In this trial, participants will undergo a minimally invasive procedure using the PeriCut Catheter System to create a small opening in the heart's outer layer, reducing pressure. Early findings suggest this method may alleviate symptoms associated with high heart pressure. Although further research is necessary, initial results appear promising for individuals with this type of heart failure. ^{2 3 4 6 7}

Who Is on the Research Team?

Dr. Barry Borlaug

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 30 with heart failure who've been hospitalized before, have signs of fluid in the lungs or high NT-proBNP levels, and show evidence of a stiff heart on tests. They must be able to walk and do an exercise test. People can't join if they're wheelchair-dependent or have other reasons for shortness of breath.

Inclusion Criteria

I am 30 years old or older.

My heart's pumping ability is good, with an ejection fraction of 50% or higher.

I can walk and complete exercise tests without needing a wheelchair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Subjects will undergo minimally invasive pericardiotomy under fluoroscopic guidance and general anesthesia using the PeriCut Catheter System

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PeriCut Catheter System

Trial Overview The study is testing the PeriCut Catheter System's ability to safely perform a minimally invasive procedure that creates an opening in the pericardium (the sac around the heart) in patients with a type of heart failure where the pumping strength remains normal but the heart is stiff.

How Is the Trial Designed?

Group I: Single Arm - Procedure & Follow up Experimental Treatment 1 Intervention

Subjects will undergo minimally invasive pericardiotomy under fluoroscopic guidance and general anesthesia using the PeriCut Catheter System

Who Is Running the Clinical Trial?

Heart Failure Solutions, Inc.

Lead Sponsor

Trials

1

Recruited

10+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/93b22d20bd1b42ff/nct06702501-minimally-invasive-pericardiotomy-heart-failure-treatment

The PeriCut Catheter System Early Feasibility Study ... Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure · Periareolar Approach in Minimally Invasive Cardiac Surgery · Feasibility Clinical Trial ...

2. clinconnect.io clinconnect.io/trials/NCT06702501

The PeriCut Catheter System Early Feasibility Study The REIMAGINE-HFpEF study is looking into a new way to help patients with heart failure who have a preserved ejection fraction, meaning their ...

3. withpower.com withpower.com/trial/phase-heart-failure-diastolic-10-2024-21f56

PeriCut Catheter System for Heart Failure The REIMAGINE-HF medical study, being run by Heart Failure Solutions, Inc., is evaluating whether PeriCut Catheter System will have tolerable side effects ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16204662/

Evaluation study of congestive heart failure and pulmonary ... Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures with ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ehf2.15401?af=R

Phenotype characterization of heart failure with preserved ... Aims. Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06702501

The PeriCut Catheter System Early Feasibility Study ... Recent (< 30 days) hospitalization for heart failure · Left (> 6 cm) ventricular dilation noted on cardiac imaging study (echocardiography or MRI) within 6 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6233816/

One-Year Safety and Clinical Outcomes of a Transcatheter ... Cumulative 12-Month Incidence of Major Adverse Cardiac, Cerebrovascular, and Renal Events and Heart Failure Events Requiring Intravenous Diuretic Treatment, ...