Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure With Preserved Ejection Fraction - The PeriCut Catheter System Early Feasibility Study (REIMAGINE HFpEF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Heart Failure Solutions, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Assessment of Safety
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Detailed Description
The PeriCut EFS is a non-randomized, open label, multi-site study testing a new minimally invasive pericardiotomy device for the treatment of heart failure with preserved ejection fraction (HFpEF).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assessment of Safety
Time Frame: 30 day follow up
Characterize the incidence of serious device and procedure related safety events at 30 days post procedure
Assessment of Acute Procedural Success
Time Frame: 30 day follow up
Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure