InterSEPT: In‐Tunnel SeptRx European PFO Trial

Heart Defects, Congenital Clinical Trial

— InterSEPT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01385670
• Other study ID #: InterSEPT
• 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. 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

Related Conditions & MeSH terms

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

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