InterSEPT: In-Tunnel SeptRx European PFO Trial

Study Overview
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Brief Summary
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The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of their PFO defects.

Official Title
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InterSEPT: In-Tunnel SeptRx European PFO Trial: A Prospective, Multi-Center Study to Evaluate the Safety and Performance of the SeptRx IPO PFO Closure System

Conditions
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Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects

Intervention / Treatment
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* Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥ 18 years of age and ≤ 70 years of age The patient is willing to comply with specified follow-up evaluations The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, approved by the appropriate Ethics Committee (EC) PFO flat width of 4-14mm (approximate PFO balloon diameter of 2.5-9mm) and PFO length of 4-20mm Exclusion Criteria: Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure Other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, Nitinol, and/or contrast sensitivity that cannot be adequately pre-medicated Currently participating in another investigational study, or participation in another clinical trial in the previous 3 months PFO flat width <4mm or >14mm to begin the trial. PFO flat width <4mm or >19mm when the second size device is ready PFO length <4mm or >20mm Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis History of chronic or sustained arrhythmia Congenital or structural heart disease other than PFO Thrombus at the intended site of implant or documented venous thrombosis in venous access Severe pulmonary hypertension Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction Acute appendicitis Confinement to bed (increased risk for clot formation) Prior cardiac surgery, including implantation of active cardiac devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)|Transcatheter PFO closure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery |  | One (1) month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Device success defined as PFO closure at 6 months post procedure by transesophageal echocardiography (TEE) with contrast valsalva bubble study. |  | Six (6) months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patent Foramen Ovale, PFO