At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,015 enrolled
Drug / intervention
Vernakalantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
In Brief
An observational study evaluating Vernakalant for Atrial Fibrillation. Completed, enrolled 2,015 participants across 6 sites in 6 countries.
Detailed Summary
This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesAustria, Denmark, Finland, Germany, Spain, Sweden
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartAug 2011
Primary CompletionApr 2018
Study CompletionMay 2018
TodayJul 2026
First PostedJun 10, 2011
Enrollment StartAug 1, 2011
Primary CompletionApr 5, 2018
Study CompletionMay 8, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 15.1 years ago
Interventions
Vernakalantdrug
Prescribed at the discretion of the physician in accordance with their usual practice