Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and septum secondum composing the interatrial septum. This foramen ovale is permeable during intra-uterine life...
Eligibility Criteria
Inclusion
- Patient whose age ≥ 18 years
- Patient with cryptogenic ischemic stroke
- Patient with FOP / ASA in trans-esophageal echocardiography
- Patient with spontaneous and / or induced Shunt R/L
- ROPE score\> 5
- Patient with medical insurance
- Francophone patient
- Patient giving free, informed and express consent
Exclusion
- Patient with a stroke with known etiology
- Patient with atrial fibrillation
- Patient with emboligenic heart disease
- Patient with carotid stenosis
- Patient with infectious endocarditis
- Patient with uncontrolled hypertension
- Patient for whom the percutaneous closure of the FOP is performed by a medical device under evaluation
- Patient under tutorship or curatorship
- Patient deprived of liberty
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2027
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT03828825
Start Date
February 1 2019
End Date
April 30 2027
Last Update
August 9 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
2
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
3
Centre Cardiologique du Nord
Saint-Denis, France, 93200