The primary objective of the study is to demonstrate the superiority of vernakalant
injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus
rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective
is to compare the safety of vernakalant to amiodarone.
Subjects will be randomized to receive vernakalant injection or amiodarone injection in a
1: 1 ratio.
Safety will be assessed through the monitoring of adverse events, vital signs, continuous
telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
At 2 hours after the start of infusion, electrical cardioversion may be performed or rate
control medication may be administered. Class I and Class III antiarrhythmics are not to be
administered for 24 hours after the start of infusion.
Subjects are to remain in the clinic for at least 6 hours after the start of infusion.
Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a
follow-up telephone call at 30 (±3) days for assessment of serious adverse events,
concomitant medications related to serious adverse events, and recurrence of AF.
All roles were blinded with the exception of each site's designated unblinded personnel who
were responsible for randomization and preparation, dispensation and accountability of the
study medication.
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Mestrska nemocnice Caslav, Caslav 286 01, Czech Republic; Recruiting
Hana Grunfeldova, MD, Phone: 420 327 305 152, Email: grunfeldova@email.cz
Hana Grunfeldova, MD, Principal Investigator
Nemocnice Kroměříž, Kroměříž 767 55, Czech Republic; Terminated
Nemocnice Kutna Hora s.r.o. Interni Oddeleni, Kutna Hora, Czech Republic; Terminated
Nemocnice Decin Internal Medicine, Nove Město 405 02, Czech Republic; Recruiting
Michal Hondl, MD, Phone: 420 737 889 772, Email: michal.hondl@nemdc.cz
Michal Hondl, MD, Principal Investigator
VFN - III. Interni Klinika, Praha, Czech Republic; Recruiting
Tomas Janota, MD, Phone: 420-224-962-934
Tomas Janota, MD, Principal Investigator
Ustredni vojenska nemocnice Koronarni jednotka, Praha 162 00, Czech Republic; Terminated
Fakultní nemocnice v Motole, KAR, Praha 150 00, Czech Republic; Terminated
Oblastni nemocnice Pribram Interni Oddeleni, Pribram, Czech Republic; Terminated
Nemocnice v Semilech Interní oddělení, Semily, Czech Republic; Recruiting
Pavel Sabl, MD, Phone: 420-481-661-333
Pavel Sabl, MD, Principal Investigator
Nemocnice Slaný Interní oddělení, Slaný, Czech Republic; Recruiting
Ondrej Cermak, MD, Phone: 420-312-575-338
Ondrej Cermak, MD, Principal Investigator
Nemocnice Tabor, Tabor 390 03, Czech Republic; Recruiting
Jana Mikulova, MD, Phone: 420 602 692 259, Email: janamikulova@seznam.cz
Jana Mikulova, MD, Principal Investigator
Uherskohradistska nemocnice, Uherské Hradiste 686 08, Czech Republic; Recruiting
Stanislav Zemek, MD, Phone: 420 724 631 007, Email: zemeks@post.cz
Stanislav Zemek, MD, Principal Investigator
Gentofte Amtssygehus Kardiologisk afdeling, Hellerup, Denmark; Recruiting
Gitte von Jessen, Phone: 45 35 31 27 71, Email: gvj@heart.dk
Christian Torp-Pedersen, MD, Principal Investigator
Herlev Amtssygehus, Kardiologisk, Herlev 2730, Denmark; Terminated
Sygehus Vendsyssel Hjorring, Hjorring, Denmark; Recruiting
Jens Petersen, MD, Phone: 45 99 64 31 01
Jens Petersen, MD, Principal Investigator
Roskilde Amts Sygehus Køge, Koge, Denmark; Recruiting
Lone Brinksby, Phone: 45 47 32 25 56
Kim Klarlund, MD, Principal Investigator
Regionshospitalet Silkeborg, Silkeborg, Denmark; Recruiting
Malene Mortensen, Phone: 45 87 22 23 49, Email: projektM1@sc.aaa.dk
Lars Frost, MD, Principal Investigator
Viimsi Hospital, Heart Clinic, Haabneeme 74001, Estonia; Recruiting
Juri Kaik, MD, Phone: 372 5 031931, Email: Jyri.Kaik@mail.ee
Juri Kaik, MD, Principal Investigator
Pärnu Hospital Department of Cardiology, Parnu, Estonia; Recruiting
Veiko Vahula, MD, Phone: 372 44 73310
Veiko Vahula, MD, Principal Investigator
East Tallinn Central Hospital-Clinic of Cardiology, Tallinn, Estonia; Recruiting
Anne Kork, MD, Phone: 372 62 07056
Anne Kork, MD, Principal Investigator
Tartu University Hospital Heart Clinic, Tartu, Estonia; Active, not recruiting
Oulu University Hospital - Dept of Internal Medicine, Oulu 90014, Finland; Active, not recruiting
Hopital Trousseau - Service de Cardiologie, Chambray-les-Tours, France; Recruiting
Dominique Babuty, MD, Phone: 33 0 247 47 46 50
Dominique Babuty, MD, Principal Investigator
CHU de Nancy - Hopital Brabois - Service de Cardiologie, Nancy, France; Recruiting
Etienne Aliot, MD, Phone: 33 3 83 15 32 96
Etienne Aliot, MD, Principal Investigator
Hôpital Lariboisiere, Paris, France; Terminated
CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie, Strasbourg, France; Terminated
Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin, Berlin, Germany; Recruiting
Wilhelm Haverkamp, MD, Phone: 49 30 450 653366
Wilhelm Haverkamp, MD, Principal Investigator
Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie, Berlin 10117, Germany; Terminated
Herzzentrum Brandenburg in Bernau Innere Medizin, Bernau 16321, Germany; Recruiting
Christian Butter, MD, Phone: 49 3 338 694 610, Email: c.butter@immanuel.de
Christian Butter, MD, Principal Investigator
Universitätsklinikum Bonn, Med. Klinik und Poliklinik II, Bonn 53105, Germany; Terminated
Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie, Frankfurt, Germany; Recruiting
Stefan Hohnloser, MD, Phone: 49 69 6301 7404
Stefan Hohnloser, MD, Principal Investigator
Universitatsklinikum Gottingen, Herzzentrum, Gottingen 37075, Germany; Recruiting
Rolf Wachter, MD, Phone: 49 551 398920
Rolf Wachter, MD, Principal Investigator
Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie, Halle, Germany; Recruiting
Michael Buerke, MD, Phone: 49 221 4783 2401
Michael Buerke, MD, Principal Investigator
Klinik Hamburg Bambek Kardiologie, Hamburg 22291, Germany; Recruiting
Thora Botschafter, Phone: 49 40 18 18 82 6317, Email: t.botschafter@asklepios.com
Gerian Grönefeld, MD, Principal Investigator
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH, Hamburg 22527, Germany; Recruiting
Dr. Tuebler, MD, Phone: 49 40 889 009 899
Frau Hoffmann, Phone: 49 40 889 009 899, Email: hoffmann@herz-hh.de
Carsten Schwencke, MD, Principal Investigator
Medizinische Klinik, Klinikum Hannover Nordstadt, Hannover, Germany; Recruiting
Johannes Hensen, MD, Phone: 49 511 9701291
Johannes Hensen, MD, Principal Investigator
Ambulantes Herzzentrum Kassel Innere Medizin, Kassel 34121, Germany; Recruiting
Ines Pietsch, Phone: 49 (0)561 93769150
Petra Becker, Phone: 49 (0)561 93769150
Andreas Utech, MD, Principal Investigator
Klinikum der Universität Köln, Medizinische Klinik III, Köln 50924, Germany; Terminated
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen 67063, Germany; Recruiting
Petra Zaricor, Phone: 49 621 503 4354, Email: zaricorp@klilu.de
Karlheinz Seidl, MD, Principal Investigator
Carl-von Basedow-Klinikum Merseburg, Merseburg 06217, Germany; Recruiting
Frau Dr. Susanne Rode, MD, Email: S.Burghard@klinikum-saalekreis.de
Roland Prondzinsky, MD, Principal Investigator
Klinikum Pirna GmbH, Innere Medizin II, Kardiologie, Pirna, Germany; Recruiting
Christoph Axthelm, MD, Phone: 49 3501 7118 5041
Christoph Axthelm, MD, Principal Investigator
Krankenhaus Reinbek, St. Adolf-Stift, Reinbek, Germany; Recruiting
Herbert Naegele, MD, Phone: 49 40 72805158
Herbert Naegele, MD, Principal Investigator
Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie, Stuttgart 70376, Germany; Terminated
Latvian Center of Cardiology, P. Stradins Clinical University Hospital, Riga LV1002, Latvia; Recruiting
Iveta Mintale, Phone: 371 67069959, Email: iveta.mintale@stradini.lv
Andrejs Erglis, MD, Principal Investigator
Kaunas Medical University Hospital - Department of Cardiology, Kaunas, Lithuania; Active, not recruiting
Klaipeda Seamen's Hospital, Klaipeda, Lithuania; Active, not recruiting
Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology, Vilnius, Lithuania; Active, not recruiting
WCN - Department of Cardiology Rijnstate Ziekenhuls, Arnhem 6-800 TA, Netherlands; Recruiting
F F Willems, MD, Phone: 31 88 005 7543, Email: f.willem7@chello.nl
F F Willems, MD, Principal Investigator
Catharina Ziekenhuis Eindhoven, Eindhoven 5623EJ, Netherlands; Recruiting
Antoinette Spierings, Phone: 31 40 2398362, Email: carapl@cze.nl
H R Michels, MD, Principal Investigator
Groene Hart Zeikenhhaus, Gouda 2800BB, Netherlands; Recruiting
Marijke de Wit, Phone: 31 18 250 5360, Email: marijke.de.wit@ghz.nl
Mrs. Kramer, Phone: 31 18 250 5360, Email: hanneke.kramer@ghz.nl
Eric Viergever, MD, Principal Investigator
WCN - Bethesda ziekenhuis, Hoogeveen 7909 AA, Netherlands; Recruiting
S H K The, MD, Phone: 31 052 828 6222, Email: shkthe@bethesda.nl
S H K The, MD, Principal Investigator
Academisch Ziekenhuis Maastricht, Maastricht 6229 HX, Netherlands; Recruiting
Iris Partouns-Hendricks, Phone: 31 43 387 7091, Email: iris.partouns.hendricks@mumc.nl
An Moens, MD, Principal Investigator
WCN - Canisius-Wilhelmina Ziekenhuis, Nijmegen 6532 SZ, Netherlands; Recruiting
Astrid Schut, Phone: 31 24 365 8789, Email: Res.car@cwz.nl
D P Hertzberger, MD, Principal Investigator
WCN - St. Franciscus Gasthuis, Rotterdam 3045 PM, Netherlands; Recruiting
Irene Kort, Phone: 31 10 461 6790, Email: i.kort@sfg.nl
Ingrid Danse, Phone: 31 10 461 6790, Email: i.danse@sfg.nl
P R Nierop, MD, Principal Investigator
Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im., Bydgoszcz, Poland; Recruiting
Andrzej Hoffmann, MD, Phone: 48 52 3709300
Andrzej Hoffmann, MD, Principal Investigator
Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii, Gdynia, Poland; Recruiting
Pawel Miekus, MD, Phone: 48 58 6665580
Pawel Miekus, MD, Principal Investigator
Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej, Lodz, Poland; Recruiting
Marlena Broncel, MD, Phone: 48 42 2516002
Marlena Broncel, MD, Principal Investigator
Okregowy Szpital Kolejowy w Lublinie Samodzielny, Lublin, Poland; Active, not recruiting
Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie, Lublin 20-089, Poland; Recruiting
Hanna Lewandowska, MD, Phone: 48 81 740 26 75, Email: hannals@o2.pl
Hanna Lewandowska, MD, Principal Investigator
Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie, Tarnow 33-100, Poland; Terminated
Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika, Toruń 87-100, Poland; Recruiting
Bartłomiej Jończy, MD, Phone: 48 56 610 02 50, Email: bartjon@o2.pl
Bartłomiej Jończy, MD, Principal Investigator
Specjalistyczny Szpital Miejski im. Mikołaja Kopernika, Toruń 87-100, Poland; Recruiting
Lidia Pawlowicz, MD, Phone: 48 56 610 02 45, Email: lpawlowicz@ksiaznica.torun.pl
Lidia Pawlowicz, MD, Principal Investigator
Wojskowy Instytut Medyczny, CSK MON, Warszawa 00-909, Poland; Recruiting
Leszek Kubik, MD, Phone: 48 22 6816585
Leszek Kubik, MD, Principal Investigator
III Klinika Chorob Wewnetrznych i Kardiologii, Warszawa 00-382, Poland; Recruiting
Krzysztof Makowiecki, MD, Phone: 48 22 6252231
Krzysztof Makowiecki, MD, Principal Investigator
Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie, Warszawa 02-507, Poland; Recruiting
Marek Kochmański, Phone: 48 22 508 16 70
Marek Kochmański, MD, Principal Investigator
Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny, Wroclaw, Poland; Recruiting
Piotr Ponikowski, MD, Phone: 48 71 7660250
Piotr Ponikowski, MD, Principal Investigator
"Dedinje" Cardiovascular Institute, Belgrade 11040, Serbia; Recruiting
Petar Otasevic, Phone: 381 11 360 16 69, Email: potasevic@yahoo.com
Milorad Borzanovic, MD, Principal Investigator
Clinical Center of Serbia, Institute of CV Diseases, Belgrade 11000, Serbia; Recruiting
Arsen Ristic, Phone: 381 11 361 47 38
Petar Seferovic, MD, Principal Investigator
Institute of Treatment and Reahabilitation 'Niska Banja', Niska Banja 18205, Serbia; Recruiting
Bojan Ilic, Phone: 381 18 450 22 26, Email: bojanil@eunet.rs
Stevan Ilic, MD, Principal Investigator
Clinical Center Zemun, Dept. of Cardiology, Zemun 11080, Serbia; Recruiting
Predrag Milicevic, Phone: +381 11 377 27 62, Email: milicevicp@hotmail.com
Putnikovic Biljana, MD, Principal Investigator
Middle Slovak Institute of Cardiovascular Diseases (SUSCCH), Banska Bysterica 97401, Slovakia; Recruiting
Gabriela Kaliska, MD, Phone: 421 48 441 3059
Gabriela Kaliska, MD, Principal Investigator
NsP Prievidza so sidlom v Bojniciah, Bojnice 97201, Slovakia; Terminated
Slovensky ustav srdcovych a cevnych chorob, Bratislava 83348, Slovakia; Terminated
ICU, Hospital Lipt. Mikulas, Liptovsky Mikulas 03101, Slovakia; Recruiting
Peter - Kycina, MD
Peter - Kycina, MD, Principal Investigator
FN - I. interna klinika, Nitra 950 01, Slovakia; Terminated
Liva - Central Military Hospital, Ruzomberok 03401, Slovakia; Recruiting
Miroslav Urban, MD, Phone: 421 44 438 2844
Miroslav Urban, MD, Principal Investigator
Interna klinika FN Trnava, Fakultna nemocnica Trnava, Trnava 91701, Slovakia; Recruiting
Vladimir Macek, MD, Phone: 421 33 593 8251
Vladimir Macek, MD, Principal Investigator
Internal Dep. Hospital Žilina, Žilina 012 07, Slovakia; Terminated
Universitetssjukhuset MAS, Malmo, Sweden; Active, not recruiting
Universityetssjukhuset, Orebro, Orebro, Sweden; Recruiting
Lena Swedberg, Phone: 46 19 602 1000
Espen Fensgrud, MD, Principal Investigator
Akademiska Sjukhuset, Uppsala, Uppsala, Sweden; Recruiting
Yvonne Björkman, Phone: 46 18 6112738
Per Blomstrom, MD, Principal Investigator
Donetsk Regional Clinical Hospital, Donetsk, Ukraine; Terminated
City Clinical Hospital #8, Kharkiv, Ukraine; Terminated
Kiev City Clinical Hospital No 5, Coronary Care Unit, Kiev, Ukraine; Terminated
City Clinical Hospital #1 Intensive Care Unit, Kiev, Ukraine; Terminated
N.D. Strazhesko Institute of Cardiology Intensive Care Unit, Kiev, Ukraine; Terminated
Lugansk First Clinical Multiprofile Hospital #1, Cardiology, Lugansk, Ukraine; Terminated
Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction, Lviv, Ukraine; Terminated
City Clinical Hospital #9 Dept of Arrhythmia, Odessa, Ukraine; Terminated
Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada; Recruiting
Kathryn Bowes, Phone: 613 549 6666, Ext: 2738, Email: Bowesk@kgh.kari.net
Marco Sivilotti, MD, Principal Investigator
The Ottawa Hospital, Ottawa, Ontario K1Y 4E9, Canada; Recruiting
Cathy Clement, RN, Phone: 613 798 5555, Ext: 16615, Email: cclement@ohri.ca
Ian Stiell, MD, Principal Investigator
Hopital de la Cite-de-la-Sante, Laval, Quebec H7M 3L9, Canada; Recruiting
Eric Daviau, Phone: 450-668-1010, Ext: 2132, Email: recherché.cardiologie.csssl@ssss.gouv.qc.ca
Mayrand Helene, MD, Principal Investigator
Institut de Cardiologie de Montreal, Montreal, Quebec H1T 1C8, Canada; Recruiting
Constance Bossy, RN, Phone: 514 376 3330, Ext: 2884, Email: Constance.Bossy@icm-mhi.org
Denis Roy, MD, Principal Investigator
Centre Hopitalier de L'Universite de Montreal - Hotel Dieu, Montreal, Quebec H2W 1T8, Canada; Recruiting
Carole Lemay, RN, Phone: 514 890 8000, Ext: 14803, Email: recherche.cardio.hd.chum@ssss.gouv.gc.ca
Paolo Costi, MD, Principal Investigator
McGill University Health Center The Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada; Recruiting
Caroline Boudreault, Phone: 514 934 1934, Ext: 43038, Email: caroline.boudreault@muhc.mcgill.ca
Thao Huynh, MD, Principal Investigator
Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur, Terrebonne, Quebec J6V 2H2, Canada; Recruiting
Margaux David, RN, Phone: 450 654 7525, Ext: 11104, Email: chlg.rech.cardio@ssss.gouv.qc.ca
Denis-Carl Phaneuf, MD, Principal Investigator
Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Recruiting
Ashley Roach, Phone: 61 08 82222889, Email: ashley.roach@health.sa.gov.au
Julie Bradley, MD, Principal Investigator
Royal Hobart Hospital Cardiology Research, Hobart, Tasmania 7000, Australia; Recruiting
Cathy McIntosh, Phone: 61 3 6222 8287, Email: cathy.mcintosh@dhhs.tas.gov.au
Phil Roberts-Thomson, MD, Principal Investigator
Launceston General Hospital Cardiac Research Unit, Launceston, Tasmania, Australia; Recruiting
Gail McBain, Phone: 61 3 63487583, Email: gail.mcbain@dhhs.tas.gov.au
Bhuwan Singh, MD, Principal Investigator
Royal Perth Hospital Emergency Research, Perth, Western Australia 6000, Australia; Recruiting
Ellen MacDonald, Phone: 61 8 9224 1724, Email: ellen.macdonald@heath.wa.gov.au
Simon Brown, MD, Principal Investigator