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

NCT06702501 | Recruiting DMC FDA Device

• 1 other identifier: CL00001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart Failure Solutions; Heart Failure with Preserved Ejection Fraction; PeriCut; Pericardiotomy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single Arm - Procedure & Follow up

EXPERIMENTAL

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

Interventions

PeriCut Catheter System performs minimally invasive pericardiotomy DEVICE

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

Single Arm - Procedure & Follow up

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart Failure Solutions, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Corporate Website

Study Officials

• Dr. Barry Borlaug

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Strong

CONTACT

6512694640; Mark@Heartfailureinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 25, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)