Tests a catheter device that cuts the heart's outer sac in heart failure

Trial details

Who runs it

Heart Failure Solutions, Inc.

Trial code

NCT06702501

Record updated

24 July 2025

Original description

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.Read full original descriptionShow less

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

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.

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:; 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: Left (> 6 cm) ventricular dilation noted on cardiac imaging study (echocardiography or MRI) within 6 months prior to enrollment; 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; Known allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the procedure; Recent (< 30 days) hospitalization for heart failure; 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; Known pericardial disease (constriction, pericarditis, tamponade); 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); 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; Inability to comply with planned study procedures or follow-up requirements, including cardiac MRI (e.g., claustrophobia or absolute contraindication to MRI); 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; 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; Diagnosis of obstructive hypertrophic cardiomyopathy; Known infiltrative cardiomyopathy (e.g., amyloid); Active myocarditis; Untreated severe obstructive sleep apnea (if known); Enrollment or planned enrollment in another therapeutic clinical trial in the next 6 months; Women who are currently pregnant, plan to become pregnant, or are currently breastfeeding; Intolerance or contraindication to colchicine.

ClinicalTrials.gov NCT06702501