279
Participants
Start Date
February 1, 2019
Primary Completion Date
April 30, 2022
Study Completion Date
April 30, 2027
Patent Foramen Ovale closure
"The Patent Foramen Ovale closure is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis. One day after the procedure, a clinical assessment and an electrocardiogram are performed. At 3 months the consultation corresponds to a trans-thoracic echocardiography validation of the closure accompanied by a bubble test (Valsalva maneuver) and a clinical assessment. At 12 months, the visit corresponds to a consultation with a clinical assessment and an electrocardiogram. At 36-months and 60-months, the visits will be done following the on-site visits provided for in the usual care or during a telephone call from the attending cardiologist to retrieve the results of the clinical examination, electrocardiogram and MACCE (major cardiac and cerebral vascular events). A consultation dedicated to the study may be proposed to patients according to what is provided in the usual care."
Groupe Hospitalier Paris Saint-Joseph, Paris
Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson
Centre Cardiologique du Nord, Saint-Denis
Fondation Hôpital Saint-Joseph
OTHER