Atrial Fibrillation Cycle Length Measured on Transesophag... | NCT03496272

Studies
Atrial Fibrillation Cycle Length Measured on Transesophageal Echocardiography

NCT03496272

Sponsor

Pusan National University Yangsan Hospital

Status

Unknown status

Last Update Posted

Apr 12, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 5, 2018

First Posted Date

Apr 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yong Hyun Park, Associate Professor, Pusan National University Yangsan HospitalPrincipal Investigator

Lead Sponsor

Pusan National University Yangsan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AF free survival rate at 6 months after DCCV	Atrial fibrillation free state at 6 months after direct current cardioversion	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

atrial fibrillation

Exclusion Criteria:

moderate or severe mitral stenosis
prosthetic heart valve

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with non-valvular atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong Hyun Park, MD	Contact	82-55-360-2363		nadroj@pusan.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital	Recruiting	Yangsan		50612	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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