Clinical Trials Logo

Clinical Trial Summary

The investigators will prospectively estimate incidences of decompression sickness in SCUBA divers with or without patent foramen ovale (PFO). All participants will receive transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO. Clinical follow up will be undertaken 3 month after transesophageal echocardiographic evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will be reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a neurologist.


Clinical Trial Description

PFO was defined as transesophageal echocardiographic (TEE) evidence of infused microbubbles in the left atrium within three cardiac cycles after their appearance in the right atrium, at rest or during Valsalva release. If TEE finding will not be conclusive, we will decide the presence or absence of PFO with supplementary transcranial doppler. It will be blinded to participants, physicians and research persons to perform clinical follow-up. It will be not officially recorded, and will be preserved by another research person, who will not contact study participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02432131
Study type Observational [Patient Registry]
Source Sejong General Hospital
Contact
Status Completed
Phase
Start date May 2015
Completion date February 2021

See also
  Status Clinical Trial Phase
Completed NCT00196040 - The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness N/A
Recruiting NCT01934725 - Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Recruiting NCT04987008 - Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
Recruiting NCT04881578 - Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Completed NCT02400892 - Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries N/A
Recruiting NCT01385670 - InterSEPT: Inā€Tunnel SeptRx European PFO Trial N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Completed NCT00968032 - Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System N/A
Recruiting NCT05558774 - Long-term Outcomes After Percutaneous Closure of PFO
Completed NCT02127294 - Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine N/A
Recruiting NCT01149447 - Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale N/A
Enrolling by invitation NCT05025475 - Stitch Closure of PFO and Septal Repair (STITCH) N/A
Suspended NCT04339699 - NobleStitch EL STITCH Trial is a PFO Comparative Trial N/A
Recruiting NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder N/A
Withdrawn NCT03232450 - Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation N/A