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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496272
Other study ID # PNUYH-IRB-05-2016-154
Secondary ID
Status Recruiting
Phase
First received April 5, 2018
Last updated April 5, 2018
Start date January 1, 2017
Est. completion date June 30, 2021

Study information

Verified date April 2018
Source Pusan National University Yangsan Hospital
Contact Yong Hyun Park, MD
Phone 82-55-360-2363
Email nadroj@pusan.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- atrial fibrillation

Exclusion Criteria:

- moderate or severe mitral stenosis

- prosthetic heart valve

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AF free survival rate at 6 months after DCCV Atrial fibrillation free state at 6 months after direct current cardioversion 6 month
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