Prague Registry of Electric Cardioversion (PRAGUE-ECV)

June 9, 2021 updated by: Marek Sramko, Institute for Clinical and Experimental Medicine

Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 14059
        • Recruiting
        • Institute for Clinical and Experimental Medicine (IKEM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Electric cardioversion
Patients who underwent elective cardioversion for atrial arrhythmia
Procedure: Electric cardioversion
Electric cardioversion in short sedation according to established clinical practice and indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute major complications
Time Frame: 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)
Within 24 hours from the procedure
Subacute major complications
Time Frame: 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.
24 hours to 30 days after the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKV2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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