NCT01385670

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

June 28, 2011

Last Update Submit

June 29, 2011

Conditions

Foramen Ovale, PatentHeart Defects, CongenitalHeart Septal Defects

Keywords

Patent Foramen OvalePFO

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Efficacy: Device success defined as PFO closure at 6 months post procedure by transesophageal echocardiography (TEE) with contrast valsalva bubble study.

    Six (6) months

Interventions

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

Transcatheter PFO closure

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICPS: Institut Jacques Cartier

Massy, France

RECRUITING

CardioVasculäres Centrum Frankfurt

Frankfurt, Germany

RECRUITING

Related 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.

    PMID: 20850097BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, PatentHeart Defects, CongenitalHeart Septal Defects

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Beverly Tang, PhD

CONTACT

510-225-9170beverly.tang@septrx.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

DE(1)FR(1)