COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Patent Foramen Ovale Closure Reduce in SCUBA-divers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03997084
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Information provided by (Responsible Party):
Joanna Hlebowicz, Skane University Hospital

Brief 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).

Condition or disease Intervention/treatment
Patent Foramen Ovale Decompression Illness Other: phone interviews

Layout table for study information
Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Patent Foramen Ovale Closure Reduce in SCUBA-divers
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Intervention Details:
  • Other: phone interviews
    phone interviews

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all Swedish patients who had had catheter-based PFO-closure

Inclusion Criteria:

  • catheter-based PFO-closure because of DCI

Exclusion Criteria:


Layout table for additonal information
Responsible Party: Joanna Hlebowicz, MD, Associated Professor, Skane University Hospital Identifier: NCT03997084    
Other Study ID Numbers: 2017-01-01
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities