Prague Registry of Electric Cardioversion

Recruiting

• Conditions: Atrial Fibrillation; Atrial Flutter; Atrial Arrhythmia; Atrial Tachycardia
• Interventions: Procedure: Electric cardioversion

• Registration Number: NCT04919902
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-09
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Unstable patients with acute conditions requiring unplanned hospitalization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electric cardioversion	Electric cardioversion	Patients who underwent elective cardioversion for atrial arrhythmia

Primary Outcome Measures

Name	Time	Method
Subacute major complications	24 hours to 30 days after the procedure	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.
Acute major complications	Within 24 hours from the procedure	Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, heart failure etc)

Secondary Outcome Measures

Name	Time	Method
Acute minor complications	Within 24 hours from the procedure	Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)
Acute efficacy	Within 2 hours from the procedure	Presence of sinus rhythm on continous ECG (5-lead) monitoring

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Prague, Czechia