Efficacy and safety of Iranian Avecinna co. defibrillator
Not Applicable
Recruiting
- Conditions
- Atrial fibrillation, atrial flutter.Atrial fibrillation and flutter
- Registration Number
- IRCT20230809059099N2
- Lead Sponsor
- Avecinna co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 105
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
Requiring emergeny cardioversion
Hemodynamic instability
Chest pain or suspicion of acute coronary syndrome
Hypokalemia
Digoxin toxicity
Pregnancy or breastfeeding
No informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of sinus rhythm conversion. Timepoint: After cardioversion. Method of measurement: ECG.
- Secondary Outcome Measures
Name Time Method umber 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.