Atrial FibrillationPRAGUE-ECVNCT04919902
Prague Registry of Electric Cardioversion
An observational study of Atrial Fibrillation and Atrial Flutter, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- What is being tested?
- Electric cardioversion
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2020to 31 Mar 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.
Who may be able to join
- Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter
Who cannot join
- Unstable patients with acute conditions requiring unplanned hospitalization
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 14059
Marek Sramko, MD, PhD, +420731682681, marek.sramko@ikem.cz
About this study
Official title: Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias
This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.
- Being tested
- Electric cardioversion
- Keywords
- Anticoagulants, Anticoagulation, Cardioversion, NOAC, DOAC
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric cardioversionProcedure or surgery
Electric cardioversion in short sedation according to established clinical practice and indications
| Study group | Role | What they receive |
|---|---|---|
| Electric cardioversion | Patients who underwent elective cardioversion for atrial arrhythmia Receives: Procedure: Electric cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute major complications
Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, heart failure etc)
Measured: 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.
Measured: 24 hours to 30 days after the procedure
Secondary outcomes (2)
Acute minor complications
Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)
Measured: Within 24 hours from the procedure
Acute efficacy
Presence of sinus rhythm on continous ECG (5-lead) monitoring
Measured: Within 2 hours from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Sramko, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919902
- Sponsor's protocol ID
- EKV2020
- Acronym
- PRAGUE-ECV
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT04919902
- Acronym / sponsor ID
- PRAGUE-ECV / EKV2020
- Keywords
- Anticoagulants, Anticoagulation, Cardioversion, NOAC, DOAC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electric cardioversion | – | Procedure: Electric cardioversionPatients who underwent elective cardioversion for atrial arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.
Key inclusion criteria (1 listed)
- Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter
Key exclusion criteria (1 listed)
- Unstable patients with acute conditions requiring unplanned hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric cardioversionElectric cardioversion in short sedation according to established clinical practice and indications | Procedure or surgery | Electric cardioversion |
Primary outcome
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)
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.
2 secondary outcomes
Acute minor complications
Time frame: Within 24 hours from the procedure
Acute efficacy
Time frame: Within 2 hours from the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute major complications (time frame: Within 24 hours from the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.