Patent Foramen OvaleNCT03997084
Patent Foramen Ovale Closure Reduce in SCUBA-divers
An observational study of Patent Foramen Ovale and Decompression Illness, run by Skane University Hospital.
Trial summary
It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Foramen Ovale, Decompression Illness
- What is being tested?
- phone interviews
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all Swedish patients who had had catheter-based PFO-closure
Who may be able to join
- catheter-based PFO-closure because of DCI
Who cannot join
- -
About this study
It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).
- Conditions
- Patent Foramen Ovale, Decompression Illness
- Being tested
- phone interviews
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone interviewsOther
phone interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
Dives
Interview based on a questionnaire with questions focusing on the dive habits and DCI events.
Measured: 2017-01-01 until 2019-01-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jan 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Hlebowicz, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997084
- Sponsor's protocol ID
- 2017-01-01
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale Closure Reduce in SCUBA-divers
- ClinicalTrials.gov ID
- NCT03997084
- Acronym / sponsor ID
- 2017-01-01
- Conditions
- Patent Foramen Ovale, Decompression Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- 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.
It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all Swedish patients who had had catheter-based PFO-closure
Key inclusion criteria (1 listed)
- catheter-based PFO-closure because of DCI
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| phone interviewsphone interviews | Other | – |
Primary outcome
Dives
Time frame: 2017-01-01 until 2019-01-01
Interview based on a questionnaire with questions focusing on the dive habits and DCI events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale and Decompression Illness, run by Skane University Hospital.
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 1 inclusion and 1 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dives (time frame: 2017-01-01 until 2019-01-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.