Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale (IDFFOP)
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|ClinicalTrials.gov Identifier: NCT03828825|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Patent Foramen Ovale||Other: Patent Foramen Ovale closure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Patent Foramen Ovale Closure
The percutaneous closure of Patent Foramen Ovale is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis.
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.
- Efficacy of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Month 3 ]Rate of disappearance of shunt Right / Left (D / G) by trans-thoracic echocardiography control
- Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: during the procedure ]Rate of peri-procedural complications
- Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale at 1 month [ Time Frame: Month 1 ]Rate of complications
- Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 1 ]Rate of complications
- Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 3 ]Rate of complications MACCE
- Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 5 ]Rate of complications MACCE
- Evaluation of the frequency of cases where a procedural "switch" [ Time Frame: during procedure ]Patients number for whom procedural "switch" (trans-thoracic echocardiography control discontinuation with trans-esophageal echocardiography) will be required
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828825
|Contact: Pryscille KAMTCHUENG, MDemail@example.com|
|Centre Chirurgical Marie Lannelongue||Not yet recruiting|
|Le Plessis-Robinson, France, 92350|
|Contact: Benoit GERARDIN, MD firstname.lastname@example.org|
|Groupe Hospitalier Paris Saint-Joseph||Recruiting|
|Paris, France, 75014|
|Contact: BEAUSSIER Hélène, PharmD 0144127038 ext +33 email@example.com|
|Centre Cardiologique du Nord||Recruiting|
|Saint-Denis, France, 93200|
|Contact: Mohammed P NEJJARI, MD firstname.lastname@example.org|
|Principal Investigator:||Pryscille KAMTCHUENG, MD||Groupe Hospitalier Paris Saint Joseph|