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RecruitingNCT04919902PRAGUE-ECVUpdated Jun 11, 2021

Prague Registry of Electric Cardioversion

An observational study in Atrial Fibrillation, Atrial Flutter and Atrial Arrhythmia, sponsored by Institute for Clinical and Experimental Medicine. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Institute for Clinical and Experimental Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Atrial Arrhythmia
  • Atrial Tachycardia

Keywords

  • Anticoagulants
  • Anticoagulation
  • Cardioversion
  • NOAC
  • DOAC
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unstable patients with acute conditions requiring unplanned hospitalization
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Electric cardioversion

    Patients who underwent elective cardioversion for atrial arrhythmia

    Procedure: Electric cardioversion

Interventions

  • ProcedureElectric cardioversion

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

06

What researchers measure

Primary outcomes

  1. Acute major complications

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

    Time frame: Within 24 hours from the procedure

  2. 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.

    Time frame: 24 hours to 30 days after the procedure

Secondary outcomes

  1. Acute minor complications

    Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)

    Time frame: Within 24 hours from the procedure

  2. Acute efficacy

    Presence of sinus rhythm on continous ECG (5-lead) monitoring

    Time frame: Within 2 hours from the procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2020 (actual). Primary completion is estimated for Dec 2024, 59 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 59 months is above that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2021
First posted
Jun 9, 2021
StartActual
Jan 1, 2020
Primary completionEst.
Dec 31, 2024
CompletionEst.
Mar 31, 2025
Last update
Jun 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04919902
Lead sponsor
Institute for Clinical and Experimental Medicine
Responsible party
Marek Sramko (Head of the Department of Acute Cardiology, Institute for Clinical and Experimental Medicine) — Principal investigator
First posted
Jun 9, 2021
Start date
Jan 1, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jun 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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