InterSEPT: In‐Tunnel SeptRx European PFO Trial (InterSEPT)
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ClinicalTrials.gov Identifier: NCT01385670 |
Recruitment Status
: Unknown
Verified June 2011 by SeptRx, Inc..
Recruitment status was: Recruiting
First Posted
: June 30, 2011
Last Update Posted
: June 30, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Foramen Ovale, Patent Heart Defects, Congenital Heart Septal Defects | Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | June 2012 |
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Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
- Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re‐intervention or surgery [ Time Frame: One (1) month ]
- Efficacy: Device success defined as PFO closure at 6 months post procedure by transesophageal echocardiography (TEE) with contrast valsalva bubble study. [ Time Frame: Six (6) months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

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): NCT01385670
Contact: Beverly Tang, PhD | 510-225-9170 ext 102 | beverly.tang@septrx.com |
France | |
ICPS: Institut Jacques Cartier | Recruiting |
Massy, France | |
Principal Investigator: Jean-François Piéchaud, MD | |
Germany | |
CardioVasculäres Centrum Frankfurt | Recruiting |
Frankfurt, Germany | |
Principal Investigator: Horst Sievert, MD |
Publications:
Responsible Party: | Beverly Tang, SeptRx, Inc. |
ClinicalTrials.gov Identifier: | NCT01385670 History of Changes |
Other Study ID Numbers: |
InterSEPT |
First Posted: | June 30, 2011 Key Record Dates |
Last Update Posted: | June 30, 2011 |
Last Verified: | June 2011 |
Keywords provided by SeptRx, Inc.:
Patent Foramen Ovale PFO |
Additional relevant MeSH terms:
Heart Septal Defects Congenital Abnormalities Heart Defects, Congenital Foramen Ovale, Patent |
Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Heart Septal Defects, Atrial |