Early feasibility of the PeriCut Catheter System for a minimally invasive pericardiotomy in HFpEF

Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure With Preserved Ejection Fraction - The PeriCut Catheter System Early Feasibility Study (REIMAGINE HFpEF)

This will test a minimally invasive catheter procedure (PeriCut) that creates a small opening in the pericardium to try to relieve shortness of breath in people with HFpEF who have severe symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Heart Failure Solutions, Inc. (Industry-sponsored)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06702501 on ClinicalTrials.gov

What this trial studies

The PeriCut EFS is a non-randomized, open-label, multi-site early feasibility effort of a new catheter designed to perform a minimally invasive pericardiotomy in patients with HFpEF and persistent NYHA class III–IV symptoms. Eligible adults (≥30 years) must have an ejection fraction ≥50% and objective evidence of elevated filling pressures or a prior HF hospitalization, and they undergo the PeriCut procedure to create a controlled pericardial opening. The trial focuses on technical success and short-term safety, with follow-up for procedure-related adverse events and changes in symptoms and biomarkers. The sponsor is Heart Failure Solutions, Inc., with Mayo Clinic collaborating and procedures conducted at participating clinical centers.

Who should consider this trial

Good fit: Adults aged 30 or older with HFpEF (EF ≥50%), persistent NYHA class III–IV symptoms, and objective evidence of elevated filling pressures or prior heart-failure hospitalization who remain on diuretic therapy.

Not a fit: People with reduced ejection fraction, non-cardiac causes of dyspnea, recent decompensated heart failure within 30 days, or anatomical contraindications to pericardial access are unlikely to benefit.

Why it matters

Potential benefit: If successful, the procedure could lower heart filling pressures and relieve breathlessness, potentially reducing hospital visits and improving quality of life.

How similar studies have performed: Pericardial modification for HFpEF is a novel approach with only limited early-phase data from small feasibility efforts, so broader effectiveness has not yet been proven.

Eligibility criteria

Inclusion Criteria

* 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:

Any previous hospitalization for HF (\>30 days prior to enrollment) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) or Elevated NT-proBNP (\>300 pg/ml or \>600 pg/ml if in atrial fibrillation) or Echocardiographic evidence of diastolic dysfunction/elevated filling pressures manifested by medial E/e' ratio ≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure or Historical catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25), prior to consent.

* 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 Criteria

* 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.

Active collagen vascular disease

* 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

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Dr. Barry Borlaug — Mayo Clinic
• Study coordinator: Mark Strong

Conditions Heart Failure With Preserved Ejection Fraction; Heart Failure Solutions; Heart Failure with Preserved Ejection Fraction; PeriCut; Pericardiotomy