Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder

NACompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 10, 2020

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2024

Conditions
Foramen Ovale, PatentNickel SensitivityDermatitis Contact IrritantMetal Allergy
Interventions
DEVICE

Percutaneous Patent Foramen Ovale Closure

Patients with well-documented embolic stroke of unknown source (ESUS) and a patent foramen ovale (PFO) are indicated for percutaneous closure of PFO. The intervention is performed through the right femoral vein. The interventional cardiologist introduces the sheath and advances the device via inferior vena cava to right atrium. Then, the catheter is passed through the PFO, the device is deployed and the occlusion is achieved. The procedure is performed under fluoroscopy guidance with or without transesophageal echocardiography guidance.

Trial Locations (1)

115 28

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens, Athens

All Listed Sponsors
lead

National and Kapodistrian University of Athens

OTHER

NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder | Biotech Hunter | Biotech Hunter