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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.
 
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
Sponsor:
Information provided by:
SeptRx, Inc.

Tracking Information
First Submitted Date  ICMJE June 28, 2011
First Posted Date  ICMJE June 30, 2011
Last Update Posted Date June 30, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE InterSEPT: In-Tunnel SeptRx European PFO Trial
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Foramen Ovale, Patent
  • Heart Defects, Congenital
  • Heart Septal Defects
Intervention  ICMJE Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
Transcatheter PFO closure
Study Arms  ICMJE Not Provided
Publications * Zimmermann WJ, Heinisch C, Majunke N, Staubach S, Russell S, Wunderlich N, Sievert H. Patent foramen ovale closure with the SeptRx device initial experience with the first "In-Tunnel" device. JACC Cardiovasc Interv. 2010 Sep;3(9):963-7. doi: 10.1016/j.jcin.2010.04.019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2011)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01385670
Other Study ID Numbers  ICMJE InterSEPT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beverly Tang, SeptRx, Inc.
Study Sponsor  ICMJE SeptRx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SeptRx, Inc.
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP