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Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study — FROST-HF  

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

Official title:
Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Heart Failure With Reduced Ejection Fraction (HFrEF)
Clinical Trial Details
NCT number NCT05136820
Study type Interventional
Source Occlutech International AB
Contact
Status Active, not recruiting
Phase N/A
Start date March 9, 2023
Completion date February 2029
View Details
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