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Early Study of PeriCut Catheter System for Heart Failure with Preserved Ejection Fraction

This study is testing a new device called the PeriCut Catheter System for people with heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart muscle pumps normally, but the heart is too stiff to fill properly. The PeriCut Catheter System is designed to make a small cut in the sac around the heart (pericardium) to help reduce pressure. This early study will look at how safe the device is and if the procedure can be done successfully. You may be able to join if you are at least 30 years old, have severe shortness of breath, and an ejection fraction (a measure of how well your heart pumps) of 50% or more. The study plans to enroll 10 participants.

Study design
This is an early study that is not randomized, meaning participants are not assigned to different groups by chance. It is an open-label study, so both you and your doctors will know what treatment you are receiving. The study plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the success of the procedure will be checked at 30 days after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06702501

The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)

Recruiting
NAAges 30+InterventionalTreatment
Heart Failure Solutions, Inc.
~10 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:PeriCut Catheter System performs minimally invasive pericardiotomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Safety
Measured over 30 day follow up
+1 more outcome measured

Conditions

Heart Failure With Preserved Ejection Fraction

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Dr. Barry Borlaug · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Mark Strong
[email protected]
6512694640
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 30 years
Symptoms of severe dyspnea (NYHA Class III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection fraction of ≥50%, determined on most recent imaging study within the preceding 2 years (730 days), with no change in clinical status, suggesting potential for deterioration in systolic function.
Documentation history of at least one of the following:
Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) during the screening/baseline visit (after consent)
Ambulatory with ability to complete 6-minute walk and cardiopulmonary exercise test (not wheelchair / scooter dependent)

Exclusion

Recent (\< 30 days) hospitalization for heart failure
Left (\> 6 cm) ventricular dilation noted on cardiac imaging study (echocardiography or MRI) within 6 months prior to enrollment.
Any hemoglobin (Hgb) \< 8.0 g/dl within 30 days prior to enrollment
Any GFR \< 20 ml/min/1.73 m2 within 30 days prior to enrollment
Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease or ischemia that is a primary contributor to symptoms, in the opinion of the Investigator.
Myocardial infarction (MI), unstable angina, catheter ablation for atrial fibrillation, biventricular pacing device implant, or percutaneous coronary intervention (PCI) within 90 days prior to enrollment
Any prior cardiac surgery
Documented stroke, CVA, TIA, deep vein thrombosis, pulmonary emboli, or suspected neurological event within 180 days prior to enrollment
Diagnosis of obstructive hypertrophic cardiomyopathy
Known infiltrative cardiomyopathy (e.g., amyloid)
Known pericardial disease (constriction, pericarditis, tamponade)
Known allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the procedure.
Active myocarditis
Significant congenital anomaly, anatomic, or comorbid medical problem that, in the opinion of the Investigator, would preclude enrollment in the study.
Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
Acute or chronic severe liver disease, as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.7 in the absence of anticoagulation treatment.
Untreated severe obstructive sleep apnea (if known)
Implantation or planned implantation of any left atrial shunts or implantable devices used to treat heart failure.
Terminal illness (other than HF) with expected survival of less than 1 year
Enrollment or planned enrollment in another therapeutic clinical trial in the next 6 months.
Inability to comply with planned study procedures or follow-up requirements, including cardiac MRI (e.g., claustrophobia or absolute contraindication to MRI)
Women who are currently pregnant, plan to become pregnant, or are currently breastfeeding.
Intolerance or contraindication to colchicine

What this trial measures

  • Assessment of Safety30 day follow up

    Characterize the incidence of serious device and procedure related safety events at 30 days post procedure

  • Assessment of Acute Procedural Success30 day follow up

    Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure