MedTrace Logo

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

NCT06702501 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

DEVICE

PeriCut Catheter System performs minimally invasive pericardiotomy

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Heart Failure Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Barry Borlaug · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702501 on ClinicalTrials.gov