Actively Recruiting
The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
Led by Heart Failure Solutions, Inc. · Updated on 2025-07-24
10
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
H
Heart Failure Solutions, Inc.
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 30 years
- Severe dyspnea symptoms (NYHA Class III-IV) without non-cardiac or ischemic cause
- Ejection fraction 63 50% on imaging within past 2 years with stable clinical status
- History of hospitalization for heart failure (>30 days ago) with pulmonary congestion or elevated NT-proBNP or echocardiographic signs of diastolic dysfunction
- Elevated heart filling pressures documented by catheterization at screening
- Ambulatory with ability to complete 6-minute walk and exercise tests (not wheelchair/scooter dependent)
You will not qualify if you...
- Recent hospitalization for heart failure (<30 days)
- Left ventricular dilation > 6 cm on imaging within 6 months
- Hemoglobin < 8.0 g/dl within 30 days
- Glomerular filtration rate < 20 ml/min/1.73 m2 within 30 days
- Significant alternative causes of dyspnea such as severe COPD or ischemia
- Recent MI, unstable angina, catheter ablation, biventricular pacing, or PCI within 90 days
- Any prior cardiac surgery
- Recent stroke, TIA, DVT, pulmonary emboli, or neurological event within 180 days
- Obstructive hypertrophic cardiomyopathy
- Known infiltrative or pericardial heart disease
- Allergy or sensitivity to contrast media that can't be pre-treated
- Active myocarditis
- Significant congenital, anatomic, or comorbid medical problems
- Active collagen vascular disease
- Significant valvular heart disease
- Severe liver disease with encephalopathy, bleeding, or high INR
- Untreated severe obstructive sleep apnea
- Left atrial shunts or implantable devices for heart failure
- Terminal illness with expected survival <1 year
- Participation in another therapeutic clinical trial in next 6 months
- Inability to comply with study procedures or MRI contraindications
- Women pregnant, planning pregnancy, or breastfeeding
- Intolerance or contraindication to colchicine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
M
Mark Strong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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