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

Official title

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

Overview

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).

Interventions

• Device PeriCut Catheter System performs minimally invasive pericardiotomy
  The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.

Primary outcome measures

• Assessment of Safety [Time frame: 30 day follow up]
• Assessment of Acute Procedural Success [Time frame: 30 day follow up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Mayo Clinic — Rochester

Identifiers

NCT: NCT06702501 · CL00001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗