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Inferiority of ZOLL and SAIRAN Electroshocks

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190608043836N1
Enrollment
670
Registered
2019-08-22
Start date
2019-09-23
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation. Atrial fibrillation and flutter

Interventions

Intervention 1: 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 t

Sponsors

Sairan medical company
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Atrial fibrillation Definite candidate for Synchronized Electrical Cardioversion to convert cardiac rhythm from atrial fibrillation to sinus rhythm Satisfaction

Exclusion criteria

Exclusion criteria: complicated disorders (advanced cancers, severe kidney problems (Glomerular filtration rate <30), liver problems, etc) Lack of necessary conditions for Synchronized Electrical Cardioversion

Design outcomes

Primary

MeasureTime frame
Cardiac rhythm status after electroshock. Timepoint: As soon as it occurs after starting the intervention. Method of measurement: Monitoring of cardiac rhythm.

Secondary

MeasureTime frame
The number of shocks performed to achieve success (sinus cardiac rhythm). Timepoint: After starting intervention. Method of measurement: counting and recording in questionnaire.;Energy consumed to achieve success. Timepoint: After starting intervention. Method of measurement: observing device monitor and recording in questionnaire.;Needing to use a temporary pacemaker to adjust the heart rate after performing a shock. Timepoint: After starting intervention. Method of measurement: questionnaire.;Heart pulses marked correctly. Timepoint: After starting intervention. Method of measurement: questionnaire.;Skin burning at electrodes spots. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.;Severity of skin burning at electrodes spots. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.;Burn wound area. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and recording in questionnaire.;Thromboembolic events after Electroshock. Timepoint: in 12th and 24th hour after intervention. Method of measurement: observing and writing in questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Mansouri

Interventional Cardiology Research Center, Cardiovascular Research institute, Isfahan University of

mansouri_a@alumnus.tums.ac.ir+98 31 3611 5215

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026