The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Registration Number
- NCT06702501
- Lead Sponsor
- Heart Failure Solutions, Inc.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessment of Safety 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 30 day follow up Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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