The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
Recruiting
N/A
Interventional Study
Heart Failure With Preserved Ejection Fraction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 30 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Heart Failure Solutions, Inc. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria
* Age ≥ 30 years
* Symptoms of severe dyspnea (NYHA Class III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
* Ejection fraction of ≥50%, determined on most recent imaging study within the preceding 2 years (730 days), with no change in clinical status,…
Contacts