Comparing Effectiveness and Safety of Synchronized Electrical Cardioversion by ZOLL and SAIRAN Electroshocks in Patients with Atrial Fibrillation: A Non-Inferiority Double Blinded Randomized Clinical Trial
Comparing Effectiveness and Safety of Synchronized Electrical Cardioversion by ZOLL and SAIRAN Electroshocks in Patients with Atrial Fibrillation: A Non-Inferiority Double Blinded Randomized Clinical Trial
Design
A concealed, randomized, single blinded, controlled clinical trial with a parallel group design of 671 patients
Settings and conduct
Setting of study: Chamran Heart Center, Isfahan, Iran
Type of randomization: Block randomization (block size = 4).
Blinding: double blinded (patient and data analyser will be blinded)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Atrial fibrillation; Definite candidate for Synchronized Electrical Cardioversion to restore AF rhythm to sinus rhythm; and Satisfaction
Non-inclusion criteria:
Problematic disorders (advanced cancers, severe kidney problems ( Glomerular filtration rate <30), liver problems, etc) and Not having the necessary conditions for Synchronized Electrical Cardioversion
Intervention groups
1 Intervention group: patients treated by SAIRAN Electroshock; control group: 2 patients treated by Zoll Electroshock.
Intervention in this study is performing Electrical Cardioversion in patients with atrial fibrillation to change their cardiac rhythm from fibrillation state to sinus state. Patients will be randomly assigned to one of aforementioned groups and treated by Electroshock.
Main outcome variables
status of cardiac rhythm after electroshock
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190608043836N1
Registration date:2019-08-22, 1398/05/31
Registration timing:prospective
Last update:2019-08-22, 1398/05/31
Update count:0
Registration date
2019-08-22, 1398/05/31
Registrant information
Name
Asieh Mansouri
Name of organization / entity
Interventional Cardiology Research Center, Cardiovascular Research institute, Isfahan University of
Country
Iran (Islamic Republic of)
Phone
+98 31 3611 5215
Email address
mansouri_a@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effectiveness and Safety of Synchronized Electrical Cardioversion by ZOLL and SAIRAN Electroshocks in Patients with Atrial Fibrillation: A Non-Inferiority Double Blinded Randomized Clinical Trial
Public title
Inferiority of ZOLL and SAIRAN Electroshocks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Atrial fibrillation
Definite candidate for Synchronized Electrical Cardioversion to convert cardiac rhythm from atrial fibrillation to sinus rhythm
Satisfaction
Exclusion criteria:
complicated disorders (advanced cancers, severe kidney problems (Glomerular filtration rate <30), liver problems, etc)
Lack of necessary conditions for Synchronized Electrical Cardioversion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
670
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization (block size=4) is used for random allocation of patients. Using RANDBETWEEN command in excell program, we determined sequence of blocks. With a sample and block size 670 and 4, respectively, RANDBETWEEN will be run for 168 times. After determining sequence of all blocks, a patient-specific 5-digits code will be written on a paper. Then paper is folded and put in a dark and thick sealed envelop. Envelops will be numbered from 1 to 670 according to blocks sequences. The meaning of 5-digits code will not be clear for patients so we will have concealment. only assessors (physician) who open envelop will be informed that how they distinguish the brand of device (SaIran or Zoll). A trained and blind nurse will preserve sealed envelops securely and deliver them to assessor (physician) one at the time according to numbering on it. For example, when first patient enters to study, the first envelope, numbered 1 on it, is delivered by the responsible nurse to the physician. Physician will open it and select type of electroshok device for patient based on 5-digits code. This work will be repeated until last patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
There is no possibility for blinding of assessors (physicians) due to the fact that the Zoll is known to all. However, patients will be blinded via masking device brand. In addition, we will blind data analyser. So this will be a double blinded study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Floor 2, Bleeding No.4, Isfahan University of M Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.125
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
cardiac rhythm status after electroshock
Timepoint
As soon as it occurs after starting the intervention
Method of measurement
Monitoring of cardiac rhythm
Secondary outcomes
1
Description
The number of shocks performed to achieve success (sinus cardiac rhythm)
Timepoint
After starting intervention
Method of measurement
counting and recording in questionnaire
2
Description
Energy consumed to achieve success
Timepoint
After starting intervention
Method of measurement
observing device monitor and recording in questionnaire
3
Description
Needing to use a temporary pacemaker to adjust the heart rate after performing a shock
Timepoint
After starting intervention
Method of measurement
questionnaire
4
Description
Heart pulses marked correctly
Timepoint
After starting intervention
Method of measurement
questionnaire
5
Description
skin burning at electrodes spots
Timepoint
in 12th and 24th hour after intervention
Method of measurement
observing and recording in questionnaire
6
Description
severity of skin burning at electrodes spots
Timepoint
in 12th and 24th hour after intervention
Method of measurement
observing and recording in questionnaire
7
Description
Burn wound area
Timepoint
in 12th and 24th hour after intervention
Method of measurement
observing and recording in questionnaire
8
Description
Thromboembolic events after Electroshock
Timepoint
in 12th and 24th hour after intervention
Method of measurement
observing and writing in questionnaire
Intervention groups
1
Description
Intervention group: Group treated by Electroshock of Sa-Iran. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thrombotic events, Burn wound status, etc.) in 12 and 24 hours after performing shock.
Category
Treatment - Devices
2
Description
Control group: group treated by Electroshock of Zoll. Before the shock, the first part of the questionnaire, which includes demographic data and risk factors, is completed by the patient's nurse. Then patient is allocated to Sa-Iran or Zoll group. After randomizations, the patient is prepared for the shock. The patient's nurse completes the second part of the questionnaire, which includes shock data (number of shocks performed to achieve success, number of used paddles, etc.) under supervision of physician. Patients is followed up at least for 24 hours after procedure in hospital. Patient's nurse completes the third part of the questionnaire, which includes complications data (thromboembolic events, Burn wound status, etc.) in 12 and 24 hours after performing shock.