RecruitingNot ApplicableNCT06702501

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

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


Sponsor

Heart Failure Solutions, Inc.

Enrollment

10 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This early-stage study is testing a new catheter device (PeriCut) that is placed in the space around the heart to help relieve fluid buildup and reduce pressure in patients with a type of heart failure where the heart muscle squeezes normally but doesn't relax properly (called heart failure with preserved ejection fraction, or HFpEF). **You may be eligible if...** - You are 30 or older - You have severe shortness of breath at rest or with minimal activity (NYHA Class III or IV) - Your heart's pumping function is normal or near-normal (ejection fraction ≥50%) - You have been hospitalized for heart failure before, or have evidence of high pressure inside the heart on tests - You are able to walk and complete exercise tests (not wheelchair-dependent) **You may NOT be eligible if...** - You were hospitalized for heart failure in the past 30 days - Your heart is significantly enlarged - You have other conditions that explain your breathlessness, not related to the heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPeriCut Catheter System performs minimally invasive pericardiotomy

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


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT06702501


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