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

NCT01854281 | Completed Results

• 1 other identifier: EK-1929/12
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patent Foramen Ovale

Keywords

Patent foramen ovale; Catheter-based closure; Nitrogen bubbles; Decompression sickness

Outcome Measures

Primary Outcomes (1)

• Arterial Nitrogen Bubbles After Surfacing

  Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.

  assesed within 1 hour after surfacing

Study Arms (4)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
• signed informed consent

You may not qualify if:

• another dive performed in the preceding 24 hours
• another previously diagnosed right-to-left shunt
• disagreement to be included in the study

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

Department of Cardiology, University Hospital Motol

Prague, 15006, Czechia

Location

Related Publications (1)

• 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.

  PMID: 24630875 DERIVED

MeSH Terms

Conditions

Foramen Ovale, Patent; Decompression Sickness

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Barotrauma; Wounds and Injuries

Results Point of Contact

• Title: Jakub Honek, MD
• Organization: University Hospital Motol

jakub.honek@gmail.com

+42022443

Study Officials

• Josef Veselka, MD, PhD

  Department of Cardiology, UH Motol

  STUDY CHAIR

• Jakub Honek, MD

  Department of cardiology, UH Motol

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 15, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

CZ (1)