Clinical trial NCT03828825: Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale
Official title: Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patent Foramen Ovale
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and allows inter-auricular communication. It tends to close at birth, due to increased pressure from the left atrium. However, it remains permeable in almost 25% of the general population. Several studies have shown that this cardiac "anomaly" associated with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a cardiac ultrasound with a "bubble" test: a volume of micro-bubbles obtained by emulsion of saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles passing; minimal shunt \<10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt if\> 30 bubbles.

Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents stroke recurrence in young people and that this procedure is more effective than antiplatelet therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation has been observed. For some researchers, this would be explained by irritation of the atrial muscle due to the establishment of the device.

To date, only percutaneous closures made in clinical trials have been evaluated. In fact, there are no specific recommendations. The use in clinical practice of this percutaneous treatment therefore requires an evaluation of the indications but also the profile of the patients to optimize these procedures and reduce the complication rate.

The closure technique and the choice of the size of the prosthesis are not standardized. The closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE study, this rate is not specified. The procedure rate under general anesthesia is 54%. This category of patients can be assumed to use a trans-esophageal echocardiography.

The absence of specific recommendations concerning the technical modalities of this procedure lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and the use of trans-esophageal echocardiography. The objective of the study is to bring elements of standardization of the technique. As part of a "real life" study, we will evaluate the success rate of procedure under local anesthesia and under trans-thoracic echocardiography control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the re-endothelisation time of the medical device being between 1 and 3 months.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Efficacy of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
timeFrame: Month 3
Secondary outcomes:
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
timeFrame: during the procedure
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale at 1 month
timeFrame: Month 1
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
timeFrame: Year 1
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
timeFrame: Year 3
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
timeFrame: Year 5
measure: Evaluation of the frequency of cases where a procedural "switch"
timeFrame: during procedure
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Pryscille KAMTCHUENG, MD
role: PRINCIPAL_INVESTIGATOR
References: