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

Heart Failure Solutions, Inc.

Status

Enrolling

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Device: PeriCut Catheter System performs minimally invasive pericardiotomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06702501

CL00001

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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