InterSEPT: In-Tunnel SeptRx European PFO Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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Conditions

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Foramen Ovale, Patent Heart Defects, Congenital Heart Septal Defects

Keywords

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Patent Foramen Ovale PFO

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Transcatheter PFO closure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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SeptRx, Inc.

Locations

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ICPS: Institut Jacques Cartier

Massy, , France

Site Status RECRUITING

CardioVasculäres Centrum Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Countries

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France Germany

Central Contacts

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Beverly Tang, PhD

Role: CONTACT

Phone: 510-225-9170

Email: [email protected]

References

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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.

Reference Type BACKGROUND

PMID: 20850097 (View on PubMed)

Other Identifiers

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InterSEPT

Identifier Type: -

Identifier Source: org_study_id