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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01385670
Other study ID # InterSEPT
Secondary ID
Status Recruiting
Phase N/A
First received June 28, 2011
Last updated June 29, 2011
Start date June 2011

Study information

Verified date June 2011
Source SeptRx, Inc.
Contact Beverly Tang, PhD
Phone 510-225-9170
Email beverly.tang@septrx.com
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
France ICPS: Institut Jacques Cartier Massy
Germany CardioVasculäres Centrum Frankfurt Frankfurt

Sponsors (1)

Lead Sponsor Collaborator
SeptRx, Inc.

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery One (1) month Yes
Secondary Efficacy: Device success defined as PFO closure at 6 months post procedure by transesophageal echocardiography (TEE) with contrast valsalva bubble study. Six (6) months No
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