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InterSEPT: In-Tunnel SeptRx European PFO Trial (InterSEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
SeptRx, Inc.

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.

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

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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

Intervention Details:
  • Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
    Transcatheter PFO closure

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01385670

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Contact: Beverly Tang, PhD 510-225-9170 ext 102

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ICPS: Institut Jacques Cartier Recruiting
Massy, France
Principal Investigator: Jean-François Piéchaud, MD         
CardioVasculäres Centrum Frankfurt Recruiting
Frankfurt, Germany
Principal Investigator: Horst Sievert, MD         
Sponsors and Collaborators
SeptRx, Inc.
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Responsible Party: Beverly Tang, SeptRx, Inc. Identifier: NCT01385670    
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
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Defects, Congenital
Foramen Ovale, Patent
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Heart Septal Defects, Atrial