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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
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: during the procedure ]
    Rate of peri-procedural complications

  2. Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale at 1 month [ Time Frame: Month 1 ]
    Rate of complications

  3. Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 1 ]
    Rate of complications

  4. Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 3 ]
    Rate of complications MACCE

  5. Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale [ Time Frame: Year 5 ]
    Rate of complications MACCE

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Pryscille KAMTCHUENG, MD 0144127038 pkamtchueng@hpsj.fr

Locations
France
Centre Chirurgical Marie Lannelongue Not yet recruiting
Le Plessis-Robinson, France, 92350
Contact: Benoit GERARDIN, MD       b.gerardin@hml.fr   
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: BEAUSSIER Hélène, PharmD    0144127038 ext +33    crc@hpsj.fr   
Centre Cardiologique du Nord Recruiting
Saint-Denis, France, 93200
Contact: Mohammed P NEJJARI, MD       mohammed.nejjari@yahoo.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Principal Investigator: Pryscille KAMTCHUENG, MD Groupe Hospitalier Paris Saint Joseph

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03828825     History of Changes
Other Study ID Numbers: IDFFOP
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities