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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Device: PeriCut Catheter System performs minimally invasive pericardiotomy

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).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Strong; Phone Number: 6512694640; Email: Mark@Heartfailureinc.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm - Procedure & Follow up; Subjects will undergo minimally invasive pericardiotomy under fluoroscopic guidance and general anesthesia using the PeriCut Catheter System	Device: PeriCut Catheter System performs minimally invasive pericardiotomy; The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Safety	Characterize the incidence of serious device and procedure related safety events at 30 days post procedure	30 day follow up
Assessment of Acute Procedural Success	Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure	30 day follow up

Collaborators and Investigators

• Sponsor: Heart Failure Solutions, Inc.
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Dr. Barry Borlaug, Mayo Clinic

Publications and helpful links

Helpful Links

• Corporate Website

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure with Preserved Ejection Fraction; Pericardiotomy; Heart Failure Solutions; PeriCut
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CL00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes