NCT05231967

Brief Summary

Ensuring and maintaining normal sinus rhythm is critical for reducing negative outcomes in patients with atrial fibrillation (AF). Electrical direct current cardioversion is a frequently used method of restoring SR, but a significant proportion of patients later develop AF recurrence. Determining which of these patients is prone to recurrence is important for treatment modification. Left atrial kinetic energy (LAKE) is a parameter that shows left atrial mechanical function and can be calculated noninvasively by transthoracic echocardiography. LAKE is reduced in patients with AF recurrence.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Status
completed

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

May 10, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

2.1 years

First QC Date

January 29, 2022

Last Update Submit

January 29, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • sinus rhythm continue one month after cardioversion

    atrial fibrillation recurrence

    one month

Study Arms (2)

Atrial fibrillation recurrence

Atrial fibrillation recurrence one month after cardioversion

Other: Cardioversion

Sinus rhythm continue

Sinus rhythm continue one month after cardioversion

Other: Cardioversion

Interventions

CardioversionOTHER

In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm

Atrial fibrillation recurrenceSinus rhythm continue

Eligibility Criteria

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

Persistent atrial fibrillation patients.

You may qualify if:

  • persistent atrial fibrillation
  • underwent successful electrical cardioversion
  • suitable for echocardiographic imaging
  • who agreed to participate in the study

You may not qualify if:

  • significant valvular disease,
  • previous valve surgery,
  • severe left ventricular systolic dysfunction (ejection fraction \< 40%),
  • severely dilated left atrium (\> 5 cm),
  • previous ablation of atrial fibrillation, or paroxysmal atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

January 29, 2022

First Posted

February 9, 2022

Study Start

May 10, 2016

Primary Completion

May 31, 2018

Study Completion

June 30, 2018

Last Updated

February 9, 2022

Record last verified: 2022-01