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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

Study acronym: FROST-HF
StatusActive, Not Recruiting
PhaseNot applicable
Started
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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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: estimated 698 to confirmed 15
    • Study sites: 25 to 2
    v13
  2. Study sites: 22 to 25v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 22
    v11
  4. Study sites: 18 to 20v10
  5. Study sites: 12 to 18v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 8 to 12
    • Start date changed from estimate of Jan 2023 to Mar 9, 2023
    v8
  2. Study sites: 7 to 8
    • Start date: Dec 2022 to Jan 2023
    v7
  3. Study sites: 4 to 7
    • Start date: Nov 2022 to Dec 2022
    • Eligibility criteria shortened, about 228 words
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2022 to Nov 2022
    • Study sites: 0 to 4
    • Eligibility criteria shortened, about 286 words
    v5
  5. Start date: Jul 2022 to Sep 2022v4 Show 4 more changesShow less
    • Primary endpoints: 5 to 6
    • Enrollment target: 575 to 698
    • Eligibility criteria expanded, about 822 words
    • Study arms: 3 to 4
  6. Start date: Jun 2022 to Jul 2022v3
  7. Start date: Feb 2022 to Jun 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05136820
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Reduced Ejection Fraction (HFrEF)
Related terms Heart Failure
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov