Patent Foramen OvaleNCT01854281
Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
An observational study of Patent Foramen Ovale, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patent Foramen Ovale
- How many people
- 47 participants
- Where
- 1 siteCzechia
- Study dates
- May 2013to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult scuba divers with either a previously diagnosed patent foramen ovale (PFO) or after a catheter-based PFO closure. Consecutive divers that undergo a simulated dive in hyperbaric chamber will be recruited.
Who may be able to join
- previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
- signed informed consent
Who cannot join
- another dive performed in the preceding 24 hours
- another previously diagnosed right-to-left shunt
- disagreement to be included in the study
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Cardiology, University Hospital Motol
Prague, 15006
About this study
The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
Read the detailed description
The aim of this study is to determine whether catheter-based closure of patent foramen ovale (PFO) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
Ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. Divers will be observed after two different dive profiles - Dive A (dive to 18 m for 80 min bottom time) and dive B (dive to 50 m for 20 min bottom time), both performed according to US Navy Air decompression procedure 1996. For both dives two groups will be compared: Divers with PFO and divers after previous catheter-based closure of PFO.
The study will be observational. Sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. Two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen.
The primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after Valsalva maneuver).
Inclusion criteria are: 1) previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure, 2) signed informed consent
Exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study
This study will be single-center.
- Conditions
- Patent Foramen Ovale
- Keywords
- Patent foramen ovale, Catheter-based closure, Nitrogen bubbles, Decompression sickness
- Medical subject headings
- Foramen Ovale, Patent, Decompression Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patent foramen ovale dive A group | Divers with a previously diagnosed patent foramen ovale observed after Dive A. | |
| Closure dive A group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. | |
| patent foramen ovale dive B group | Divers with a previously diagnosed patent foramen ovale observed after Dive B. | |
| closure dive B group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Nitrogen Bubbles After Surfacing
Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.
Measured: assesed within 1 hour after surfacing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Honek, MD, University Hospital, Motol
- Investigators
- Josef Veselka, MD, PhD, Study chair, Department of Cardiology, UH MotolJakub Honek, MD, Study director, Department of cardiology, UH Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854281
- Sponsor's protocol ID
- EK-1929/12
- Status last verified
- Oct 2013
- First submitted
- 10 May 2013
- Last updated
- 18 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Honek J, Sramek M, Sefc L, Januska J, Fiedler J, Horvath M, Tomek A, Novotny S, Honek T, Veselka J. Effect of catheter-based patent foramen ovale closure on the occurrence of arterial bubbles in scuba divers. JACC Cardiovasc Interv. 2014 Apr;7(4):403-8. doi: 10.1016/j.jcin.2013.12.199. Epub 2014 Mar 14.
PubMed 24630875
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
- ClinicalTrials.gov ID
- NCT01854281
- Acronym / sponsor ID
- EK-1929/12
- Conditions
- Patent Foramen Ovale
- Keywords
- Patent foramen ovale, Catheter-based closure, Nitrogen bubbles, Decompression sickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 18 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
Detailed description
The aim of this study is to determine whether catheter-based closure of patent foramen ovale (PFO) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
Ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. Divers will be observed after two different dive profiles - Dive A (dive to 18 m for 80 min bottom time) and dive B (dive to 50 m for 20 min bottom time), both performed according to US Navy Air decompression procedure 1996. For both dives two groups will be compared: Divers with PFO and divers after previous catheter-based closure of PFO.
The study will be observational. Sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. Two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen.
The primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after Valsalva maneuver).
Inclusion criteria are: 1) previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure, 2) signed informed consent
Exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study
This study will be single-center.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patent foramen ovale dive A group | – | –Divers with a previously diagnosed patent foramen ovale observed after Dive A. |
| Closure dive A group | – | –Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. |
| patent foramen ovale dive B group | – | –Divers with a previously diagnosed patent foramen ovale observed after Dive B. |
| closure dive B group | – | –Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult scuba divers with either a previously diagnosed patent foramen ovale (PFO) or after a catheter-based PFO closure. Consecutive divers that undergo a simulated dive in hyperbaric chamber will be recruited.
Key inclusion criteria (2 listed)
- previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
- signed informed consent
Key exclusion criteria (3 listed)
- another dive performed in the preceding 24 hours
- another previously diagnosed right-to-left shunt
- disagreement to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial Nitrogen Bubbles After Surfacing
Time frame: assesed within 1 hour after surfacing
Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24630875Honek J, Sramek M, Sefc L, Januska J, Fiedler J, Horvath M, Tomek A, Novotny S, Honek T, Veselka J. Effect of catheter-based patent foramen ovale closure on the occurrence of arterial bubbles in scuba divers. JACC Cardiovasc Interv. 2014 Apr;7(4):403-8. doi: 10.1016/j.jcin.2013.12.199. Epub 2014 Mar 14.
Related trials for Patent Foramen Ovale
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke
RecruitingObservational study
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active, not recruitingObservational study
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Stroke, Patent Foramen Ovale
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.
Josef Veselka, MD, PhD study chair
Department of Cardiology, UH Motol
Jakub Honek, MD study director
Department of cardiology, UH Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, run by University Hospital, Motol at 1 site in Czechia.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Nitrogen Bubbles After Surfacing (time frame: assesed within 1 hour after surfacing). 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 NCT01854281, 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 18 Dec 2013.