Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Reduced Ejection Fraction (HFrEF)
In brief
The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.
Key facts
- Study ID
- NCT05136820
- Run by
- Occlutech International AB
- People needed
- 15
- Starts
- 2023-03-09
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Heart Rhythm Center — Phoenix, Arizona, United States
- North Shore Northwell University Hospital Lenox Hill — New York, New York, United States
Full record on ClinicalTrials.gov
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