N/A N=47

Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure

Patent Foramen Ovale

Bottom Line

View on ClinicalTrials.gov: NCT01854281 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Arterial Nitrogen Bubbles After Surfacing — 0; 6; 0; 7 participants — p=0.02

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University Hospital, Motol
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Arterial Nitrogen Bubbles After Surfacing	0; 6; 0; 7	0.02 sig

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.

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

View full record on ClinicalTrials.gov →

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.