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

NCT ID: NCT06702501

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-06-01

Brief 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.

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).

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm - Procedure & Follow up

Subjects will undergo minimally invasive pericardiotomy under fluoroscopic guidance and general anesthesia using the PeriCut Catheter System

Group Type: EXPERIMENTAL

PeriCut Catheter System performs minimally invasive pericardiotomy

Intervention Type: DEVICE

The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.

Interventions

PeriCut Catheter System performs minimally invasive pericardiotomy

The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Heart Failure Solutions, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Barry Borlaug

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Strong

Role: CONTACT

Mark@Heartfailureinc.com

6512694640

Related Links

http://www.heartfailureinc.com

Corporate Website

Other Identifiers

CL00001

Identifier Type: -

Identifier Source: org_study_id