NCT03496272

Brief Summary

Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or ablation therapy. The aim of this study was to test whether a AFCL measured by transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV. Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6 hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

April 5, 2018

Last Update Submit

April 5, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF free survival rate at 6 months after DCCV

    Atrial fibrillation free state at 6 months after direct current cardioversion

    6 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with non-valvular atrial fibrillation

You may qualify if:

  • atrial fibrillation

You may not qualify if:

  • moderate or severe mitral stenosis
  • prosthetic heart valve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yong Hyun Park, MD

CONTACT

82-55-360-2363nadroj@pusan.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 12, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations

KR(1)