Informations générales (source: ClinicalTrials.gov)
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 (InterSEPT)
Interventional
N/A
SeptRx, Inc. (Voir sur ClinicalTrials)
juin 2011
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PRIVE JACQUES CARTIER | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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