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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent focused on measuring Patent Foramen Ovale, PFO

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICPS: Institut Jacques CartierRecruiting
CardioVasculäres Centrum FrankfurtRecruiting

Outcomes

Primary Outcome Measures

Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01385670

First Posted

June 28, 2011

Last Updated

June 29, 2011

Sponsor

SeptRx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01385670

Brief Title

InterSEPT: In-Tunnel SeptRx European PFO Trial

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

SeptRx, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Patent Foramen Ovale, PFO

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Transcatheter PFO closure

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beverly Tang, PhD

Phone

510-225-9170

Ext

102

beverly.tang@septrx.com

Facility Information:

Facility Name

ICPS: Institut Jacques Cartier

City

Massy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-François Piéchaud, MD

Facility Name

CardioVasculäres Centrum Frankfurt

City

Frankfurt

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Horst Sievert, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20850097

Citation

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.

Results Reference

background

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InterSEPT: In-Tunnel SeptRx European PFO Trial

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