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出境医 / 临床实验 / Prague Registry of Electric Cardioversion (PRAGUE-ECV)

Prague Registry of Electric Cardioversion (PRAGUE-ECV)

Study Description
Brief Summary:
This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.

Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Flutter Atrial Arrhythmia Atrial Tachycardia Procedure: Electric cardioversion

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. 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)

  2. 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.


Secondary Outcome Measures :
  1. Acute minor complications [ Time Frame: Within 24 hours from the procedure ]
    Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)

  2. Acute efficacy [ Time Frame: Within 2 hours from the procedure ]
    Presence of sinus rhythm on continous ECG (5-lead) monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Czechia
Institute for Clinical and Experimental Medicine (IKEM) Recruiting
Prague, Czechia, 14059
Contact: Marek Sramko, MD, PhD    +420731682681    marek.sramko@ikem.cz   
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Tracking Information
First Submitted Date June 3, 2021
First Posted Date June 9, 2021
Last Update Posted Date June 11, 2021
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 9, 2021)
  • Acute minor complications [ Time Frame: Within 24 hours from the procedure ]
    Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)
  • Acute efficacy [ Time Frame: Within 2 hours from the procedure ]
    Presence of sinus rhythm on continous ECG (5-lead) monitoring
Original Secondary Outcome Measures
 (submitted: June 3, 2021)
  • Acute minor complications [ Time Frame: Within 24 hours from the procedure ]
    Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)
  • Acute efficacy [ Time Frame: Within 2 horus from the procedure ]
    Successful restoration of sinus rhythm documented by ECG monitoring
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prague Registry of Electric Cardioversion
Official Title Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias
Brief Summary This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.
Condition
  • Atrial Fibrillation
  • Atrial Flutter
  • Atrial Arrhythmia
  • Atrial Tachycardia
Intervention Procedure: Electric cardioversion
Electric cardioversion in short sedation according to established clinical practice and indications
Study Groups/Cohorts Electric cardioversion
Patients who underwent elective cardioversion for atrial arrhythmia
Intervention: Procedure: Electric cardioversion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 3, 2021) 		5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04919902
Other Study ID Numbers EKV2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Marek Sramko, Institute for Clinical and Experimental Medicine
Study Sponsor Institute for Clinical and Experimental Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Institute for Clinical and Experimental Medicine
Verification Date June 2021