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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Heart Failure Solutions, Inc.
Study ID
NCT06702501
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PeriCut Catheter System performs minimally invasive pericardiotomy — DEVICE
    The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm - Procedure & Follow up
    Subjects will undergo minimally invasive pericardiotomy under fluoroscopic guidance and general anesthesia using the PeriCut Catheter System

Primary Outcome Measure

Assessment of Safety [ Time Frame: 30 day follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Mayo Clinic· Rochester, MN

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