the pericut catheter system early feasibility study (reimagine-hfpef)

Conditions: Heart Failure With Preserved Ejection Fraction

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.

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:
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

Keywords: heart failure solutions heart failure with preserved ejection fraction pericut pericardiotomy