EUCTR2014-003641-95-ES
Active, not recruiting
Not Applicable
Randomized clinical trial to study effective pharmacological cardioversion of paroxysmal atrial fibrillation by blocking ionic currents atrioselectivas by treatment with vernakalant vs Flecainide - SELECTI-CARFAP
icasio Pérez Castellano0 sitesNovember 11, 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial fibrillation paroxysmal
- Sponsor
- icasio Pérez Castellano
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Patients with paroxysmal atrial fibrillation with less of 48 hours of evolution.
- •2 Hemodynamically stable patients (systolic blood pressure\> 100 mm Hg and \<160 mm Hg. Diastolic blood pressure \<95 mm Hg).
- •3 Weight from 45 to 136 kg.
- •4\. Adequate anticoagulant therapy according to clinical practice guidelines of European Society of Cardiology in atrial fibrillation paroxysmal duration less of 48 hours.
- •5 Aging between 20 and 65 years old.
- •6 Patients must agree and be able to grant informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1 QT interval\> 440 milliseconds, long QT familiar syndrome or previous history of Torsades de Pointes syndrome.
- •2 Symptomatic bradycardia or ventricular rate \<50 bpm without a pacemaker, or QRS interval\> 140 milliseconds.
- •3 Patients with Class IV heart failure according to the New York Heart Association or congestive heart failure requiring intravenous inotropic therapy.
- •4\. cardiogenic or septic shock, chronic myocardial infarction, acute coronary syndrome, or heart surgery in \<30 days before recruitment.
- •5 valve stenosis, obstructive hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- •6\. previous electrical cardioversion ineffective.
- •7 Having received an investigational drug within 60 days before inclusion or received vernakalant previously.
- •8 Secondary causes of atrial fibrillation, uncorrected electrolyte imbalance, or digoxin toxicity.
- •9 intravenous / oral treatment with class I or III antiarrhythmic drugs (except amiodarone) in the previous 48 hours.
- •10 intravenous / oral amiodarone within 3 months prior.
Outcomes
Primary Outcomes
Not specified
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