Foramen Ovale, PatentInterSEPTNCT01385670
InterSEPT: In-Tunnel SeptRx European PFO Trial
A study testing Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO) in people with Foramen Ovale, Patent and Heart Defects, Congenital, run by SeptRx, Inc. at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects
- What is being tested?
- Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
ICPS: Institut Jacques Cartier
Massy
Jean-François Piéchaud, MD
Germany1 site, 1 recruiting
- Recruiting
CardioVasculäres Centrum Frankfurt
Frankfurt
Horst Sievert, MD
About this study
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
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.
- Being tested
- Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)
- Keywords
- Patent Foramen Ovale, PFO
- Medical subject headings
- Foramen Ovale, Patent, Heart Defects, Congenital, Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)Device
Transcatheter PFO closure
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
Measured: 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.
Measured: Six (6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SeptRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385670
- Sponsor's protocol ID
- InterSEPT
- Acronym
- InterSEPT
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20850097
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01385670
- Acronym / sponsor ID
- InterSEPT / InterSEPT
- Keywords
- Patent Foramen Ovale, PFO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SeptRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)Transcatheter PFO closure | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Background: PubMed 20850097Zimmermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO) in people with Foramen Ovale, Patent and Heart Defects, Congenital, run by SeptRx, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beverly Tang, PhD (510-225-9170 ext. 102, beverly.tang@septrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.