NCT03997084

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

June 20, 2019

Last Update Submit

June 24, 2019

Conditions

Patent Foramen OvaleDecompression Illness

Outcome Measures

Primary Outcomes (1)

  • Dives

    Interview based on a questionnaire with questions focusing on the dive habits and DCI events.

    2017-01-01 until 2019-01-01

Interventions

phone interviewsOTHER

phone interviews

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all Swedish patients who had had catheter-based PFO-closure

You may qualify if:

  • catheter-based PFO-closure because of DCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associated Professor

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 25, 2019

Study Start

January 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share