Clinical Trial

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

Study acronym: FROST-HF
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 8, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2021-11-23; most recent amendment 2025-08-05.
Status change: Recruiting → Active, Not Recruiting 2023-09-28
Status change: Not Yet Recruiting → Recruiting 2022-11-08
Trial Details
NCT Number NCT05136820
Lead Sponsor Occlutech International AB
Conditions Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Reduced Ejection Fraction (HFrEF)
Enrollment 15 participants
Start Date 2023-03-09
Primary Completion 2026-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-08