NCT04919902

Brief Summary

This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 3, 2021

Last Update Submit

June 9, 2021

Conditions

Keywords

AnticoagulantsAnticoagulationCardioversionNOACDOAC

Outcome Measures

Primary Outcomes (2)

  • Acute major complications

    Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, heart failure etc)

    Within 24 hours from the procedure

  • Subacute major complications

    Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, acute heart failure etc), evaluated by structured phone call.

    24 hours to 30 days after the procedure

Secondary Outcomes (2)

  • Acute minor complications

    Within 24 hours from the procedure

  • Acute efficacy

    Within 2 hours from the procedure

Study Arms (1)

Electric cardioversion

Patients who underwent elective cardioversion for atrial arrhythmia

Procedure: Electric cardioversion

Interventions

Electric cardioversion in short sedation according to established clinical practice and indications

Electric cardioversion

Eligibility Criteria

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

Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.

You may qualify if:

  • Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter

You may not qualify if:

  • Unstable patients with acute conditions requiring unplanned hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14059, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

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 GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Acute Cardiology

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 9, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations