Long-Term Safety and Outcomes of Catheter-Based Patent Foramen Ovale Closure A Combined Retrospective and Prospective Observational Registry at Severance Cardiovascular Hospital

What this Trial Is About

Patent foramen ovale PFO is a common heart condition present in about one quarter of people and is linked to unexplained strokes. Researchers are studying the long-term safety and effectiveness of closing PFO using a catheter-based procedure. This observational registry combines past records of patients treated between 2010 and March 2026 with new patients enrolled after approval, tracking outcomes up to nearly 10 years. The study includes two groups one looking back at about 140 patients who had PFO closure and follow-up heart ultrasound tests, and one enrolling new patients who consent to join. Follow-up visits for new patients occur at 6, 12, 24, 48, 72, 96, and 119 months after closure. The procedure and its effects are monitored using special ultrasound tests that detect residual heart shunt, with details on device types, treatments, and other medical factors collected from records and visits. Participants undergo regular heart ultrasound scans to measure residual shunts and are monitored for clinical events such as stroke recurrence, death, device complications, and new atrial fibrillation. Data on patient health, imaging results, treatments, and functional status are gathered throughout the study. Outcomes are analyzed statistically to identify factors influencing long-term results, with the study lasting up to 16 years for some patients.

Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)