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

• ClinicalTrials.gov Identifier: NCT01385670
• Recruitment Status: Unknown
• First Posted: June 30, 2011
• Last Update Posted: June 30, 2011
• Sponsor: SeptRx, Inc.
• Information provided by: SeptRx, Inc.

Tracking Information

• First Submitted Date: June 28, 2011
• First Posted Date: June 30, 2011
• Last Update Posted Date: June 30, 2011
• Study Start Date: June 2011
• Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: InterSEPT: In-Tunnel SeptRx European PFO Trial
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Foramen Ovale, Patent
• Heart Defects, Congenital
• Heart Septal Defects

Intervention

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

Transcatheter PFO closure

• Study Arms: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 29, 2011): 70
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany

Administrative Information

• NCT Number: NCT01385670
• Other Study ID Numbers: InterSEPT
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Beverly Tang, SeptRx, Inc.
• Study Sponsor: SeptRx, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: SeptRx, Inc.
• Verification Date: June 2011