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NCT06702501NARecruiting

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

Heart Failure Solutions, Inc.

Start Date

2/17/2025

Completion Date

6/1/2026

Summary

The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut Catheter System.

Detailed Description

The PeriCut EFS is a non-randomized, open label, multi-site study testing a new minimally invasive pericardiotomy device for the treatment of heart failure with preserved ejection fraction (HFpEF).

Eligibility Criteria

Age Range: 30 years to No maximum

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

Interventions

DEVICE

PeriCut Catheter System performs minimally invasive pericardiotomy

Interested in This Trial?

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Conditions

Heart Failure With Preserved Ejection Fraction

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States