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
  Purpose

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 Intervention
Foramen Ovale, Patent
Heart Defects, Congenital
Heart Septal Defects
Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SeptRx, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
    Transcatheter PFO closure
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385670

Contacts
Contact: Beverly Tang, PhD 510-225-9170 ext 102 beverly.tang@septrx.com

Locations
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         
Sponsors and Collaborators
SeptRx, Inc.
  More Information

Publications:
Responsible Party: Beverly Tang, SeptRx, Inc.
ClinicalTrials.gov Identifier: NCT01385670     History of Changes
Other Study ID Numbers: InterSEPT
Study First Received: June 28, 2011
Last Updated: June 29, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 19, 2014