Trials / Recruiting
RecruitingNCT06702501
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)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Heart Failure Solutions, Inc. · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PeriCut Catheter System performs minimally invasive pericardiotomy | The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart. |
Timeline
- Start date
- 2025-02-17
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2024-11-25
- Last updated
- 2025-07-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06702501. Inclusion in this directory is not an endorsement.