N/A
Completed N=47
Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
Patent Foramen Ovale
Source: ClinicalTrials.gov NCT01854281 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Arterial Nitrogen Bubbles After Surfacing — 0; 6; 0; 7 participants — p=0.02
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Nitrogen Bubbles After Surfacing |
0; 6; 0; 7 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
- signed informed consent
Exclusion criteria
- another dive performed in the preceding 24 hours
- another previously diagnosed right-to-left shunt
- disagreement to be included in the study
Data sourced from ClinicalTrials.gov (NCT01854281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.