Vernakalant Versus Flecainide: Atrial Contractility
|ClinicalTrials.gov Identifier: NCT01646281|
Recruitment Status : Unknown
Verified July 2012 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Vernakalant Drug: Flecainide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Active Comparator: Flecainide
Patients randomized to flecainide will receive a 10-minute infusion of 2 mg/kg (maximal 150 mg) flecainide. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.
10-minute infusion of 2 mg/kg (maximal 150 mg)
Other Name: Tambocor, EV product code SUB13894MIG
Active Comparator: Vernakalant
Patients randomized to vernakalant will receive a 10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.
10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.
Other Name: Brinavess, EV product code SUB30707
- Atrial contractility measured by echocardiography [ Time Frame: After successful cardioversion to sinus rhythm (this can be during infusion of medication or during the first hour after infusion) an echocardiography will be performed within one hour. ]Echocardiography will be performed when the patient has sinus rhythm. Transmitral flow will be measured by pulsed Doppler from an apical four chamber view. Peak velocities of the early filling (E) wave and atrial filling (A) will be determined. We will also determine the E/A ratio and the atrial volumes and the total atrial conduction time (PA-TVI).
- Conversion to sinus rhythm [ Time Frame: Within one hour after drug administration ]Heart rhythm will be assessed on monitor and confirmed on ECG.
- Recurrence of AF [ Time Frame: At one month follow-up ]Heart rhythm will be assessed by ECG.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646281
|Contact: Ione Limantoro, MDfirstname.lastname@example.org|
|Contact: Harry Crijns, MD, PhDemail@example.com|
|Maastricht University Hospital||Not yet recruiting|
|Maastricht, Netherlands, 6229 HX|
|Contact: Ione Limantoro, MD +31433875119 firstname.lastname@example.org|
|Contact: Harry Crijns, MD, PhD +31433875093 email@example.com|
|Principal Investigator: Harry Crijns, MD, PhD|
|Sub-Investigator: Ione Limantoro, MD|
|Principal Investigator:||Harry Crijns, MD, PhD||Maastricht University Hospital|