- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Interventions
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Device
- Lead sponsor
- Occlutech International AB
- Industry
- Eligibility
- Not listed
- Enrollment
- 25 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2026
- U.S. locations
- 7
- States / cities
- Birmingham, Alabama • Los Angeles, California • San Diego, California + 4 more
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- Conditions
- Not listed
- Interventions
- Catheter implantation of Occlutech AFR device
- Device
- Lead sponsor
- Occlutech International AB
- Industry
- Eligibility
- Not listed
- U.S. locations
- 1
- States / cities
- Maple Grove, Minnesota
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Reduced Ejection Fraction (HFrEF)
- Interventions
- Atrial Flow Regulator, Sham Comparator
- Device
- Lead sponsor
- Occlutech International AB
- Industry
- Eligibility
- 18 Years and older
- Enrollment
- 15 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2023 – 2029
- U.S. locations
- 2
- States / cities
- Phoenix, Arizona • New York, New York