Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects
Conditions
Keywords
Patent Foramen Ovale, PFO
Brief summary
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.
Interventions
DEVICETranscatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
Transcatheter PFO closure
Sponsors
SeptRx, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France, Germany
Contacts
Primary ContactBeverly Tang, PhD
Outcome results
None listed