Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale

NAActive, not recruitingINTERVENTIONAL
Enrollment

279

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

April 30, 2022

Study Completion Date

April 30, 2027

Conditions
Patent Foramen Ovale
Interventions
OTHER

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."

Trial Locations (3)

75014

Groupe Hospitalier Paris Saint-Joseph, Paris

92350

Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson

93200

Centre Cardiologique du Nord, Saint-Denis

All Listed Sponsors
lead

Fondation Hôpital Saint-Joseph

OTHER

NCT03828825 - Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale | Biotech Hunter | Biotech Hunter