NCT02742896

Brief Summary

Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

5.3 years

First QC Date

October 5, 2014

Last Update Submit

April 20, 2024

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctioncognitive function

Outcome Measures

Primary Outcomes (1)

  • The changes of erectile function

    The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.

    Erectile dysfunction 1 year after conversion to sinus rhythm.

Secondary Outcomes (1)

  • The changes of cognitive function

    cognitive dysfunction 1 year after conversion to sinus rhythm

Study Arms (1)

Restoration of Erectile dysfunction

The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.

Other: Erectile dysfunction

Interventions

Erectile dysfunctionOTHER

The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm. The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm.

Also known as: official questionnaire
Restoration of Erectile dysfunction

Eligibility Criteria

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

Patients who are scheduled to rhythm control of persistent atrial fibrillation.

You may qualify if:

  • Patients scheduled to electrical cardioversion

You may not qualify if:

  • Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.
  • More than moderate degree of cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Yong Seog Oh, MD

    Seoul St Mary hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 5, 2014

First Posted

April 19, 2016

Study Start

December 1, 2013

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

KR(1)