InterSEPT: In‐Tunnel SeptRx European PFO Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by SeptRx, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SeptRx, Inc.
ClinicalTrials.gov Identifier:
NCT01385670
First received: June 28, 2011
Last updated: June 29, 2011
Last verified: June 2011

June 28, 2011
June 29, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01385670 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
InterSEPT: In‐Tunnel SeptRx European PFO Trial
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Foramen Ovale, Patent
  • Heart Defects, Congenital
  • Heart Septal Defects
Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
Transcatheter PFO closure
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Beverly Tang, PhD 510-225-9170 ext 102 beverly.tang@septrx.com
France,   Germany
 
NCT01385670
InterSEPT
Yes
Beverly Tang, SeptRx, Inc.
SeptRx, Inc.
Not Provided
Not Provided
SeptRx, Inc.
June 2011

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