Prague Registry of Electric Cardioversion

Atrial Fibrillation Clinical Trial

— PRAGUE-ECV  

Official title:

Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919902
• Other study ID #: EKV2020
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2021
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Acute minor complications	Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)	Within 24 hours from the procedure
Secondary	Acute efficacy	Presence of sinus rhythm on continous ECG (5-lead) monitoring	Within 2 hours from the procedure