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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.
 
ClinicalTrials.gov Identifier: NCT03997084
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
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

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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

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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
Criteria

Inclusion Criteria:

  • catheter-based PFO-closure because of DCI

Exclusion Criteria:

-

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Responsible Party: Joanna Hlebowicz, MD, Associated Professor, Skane University Hospital
ClinicalTrials.gov 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

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