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.
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At a Glance
Age
30 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Heart Failure Solutions, Inc. · Industry
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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
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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

Mark Strong

6512694640

Mark@Heartfailureinc.com

CONTACT