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Efficacy and safety of Iranian Avecinna co. defibrillator

Efficacy and safety of the Defibrillator / Monitor model Re-pulse6 Avecinna Co. among patients with atrial fibrillation and flutter who are candidates of elective cardioversion: a stratified non-inferiority randomized controlled trial at Tehran Heart Center

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230809059099N2
Enrollment
105
Registered
2024-03-01
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

Atrial fibrillation, atrial flutter. Atrial fibrillation and flutter

Interventions

Intervention 1: Intervention group: Avecinna defibrillator. In both groups patients will be sedated. antiarhythmic drug use will be recorded in CRF forms. anti-arrhythmic drugs will not be used as pre

Sponsors

Avecinna co
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Age >18 years old Atrial fibrillation or flutter indication for cardioversion Atrial fibrillation or flutter will be confirmed by an electrophysiologist using 12 lead standard ECG. Cardioversion will be conducted at the discretion of the electrophysiologist. All patients are required to receive at least 4 weeks of antio coagulation or left atrial thrombus is ruled out by trans esophageal echocardiography

Exclusion criteria

Exclusion criteria: Requiring emergeny cardioversion Hemodynamic instability Chest pain or suspicion of acute coronary syndrome Hypokalemia Digoxin toxicity Pregnancy or breastfeeding No informed consent

Design outcomes

Primary

MeasureTime frame
Rate of sinus rhythm conversion. Timepoint: After cardioversion. Method of measurement: ECG.

Secondary

MeasureTime frame
Number of times shock is required in experimental and standard device. Timepoint: After start of the cardioversion process. Method of measurement: Number.;Safety: any inflammation, burn, pain, or electrocution in experimental device compared to standard device. comparison of ventricular arrhythmias, bradycardia, or asystole.comparison of any other adverse effects. Timepoint: Immeadiately after shock. Method of measurement: Observation by the cardiologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Masoud Kabir

Tehran University of Medical Sciences

farzad.masoudkabir@gmail.com+98 21 8802 9600

Outcome results

None listed

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