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

Study Description

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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

Study Design

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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

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Responsible Party:	Beverly Tang, SeptRx, Inc.
ClinicalTrials.gov Identifier:	NCT01385670 History of Changes
Other Study ID Numbers:	InterSEPT
First Posted:	June 30, 2011
Last Update Posted:	June 30, 2011
Last Verified:	June 2011

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