Trials / Active Not Recruiting
Active Not RecruitingNCT05136820
Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Occlutech International AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF)
- Heart Failure With Reduced Ejection Fraction (HFrEF)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Atrial Flow Regulator | Subjects will be randomized 1:1:1 where subjects will either receive the 6mm AFR device, 8mm AFR device or Sham procedure. |
| DEVICE | Sham Comparator | Subjects will be randomized 1:1:1 where subjects will either receive the 6mm AFR device, 8mm AFR device or Sham procedure. |
Timeline
- Start date
- 2023-03-09
- Primary completion
- 2026-02-01
- Completion
- 2029-02-01
- First posted
- 2021-11-29
- Last updated
- 2025-08-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05136820. Inclusion in this directory is not an endorsement.