Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)

Tracking Information
First Submitted Date	June 8, 2011
First Posted Date	June 10, 2011
Last Update Posted Date	May 10, 2018
Study Start Date	August 2011
Actual Primary Completion Date	April 5, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 9, 2011)	Number of participants experiencing significant hypotension [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]; Number of participants experiencing significant ventricular arrhythmia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]; Number of participants experiencing significant atrial flutter [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]; Number of participants experiencing significant bradycardia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01370629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: June 9, 2011)	Number of participants who are converted to sinus rhythm for at least one minute [ Time Frame: Up to 90 minutes after the start (baseline) of first infusion of vernakalant ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
Official Title	A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
Brief 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
Condition	Atrial Fibrillation
Intervention	Drug: Vernakalant; Prescribed at the discretion of the physician in accordance with their usual practice; Other Name: BRINAVESS®
Study Groups/Cohorts	All participants; Participants treated with vernakalant IV in acute care and inpatient hospital settings; Intervention: Drug: Vernakalant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 9, 2018)	2013
Original Estimated Enrollment; (submitted: June 9, 2011)	2000
Actual Study Completion Date	May 8, 2018
Actual Primary Completion Date	April 5, 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: To be treated with intravenous vernakalant, independently of this study; Participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations Exclusion Criteria: - Enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. Participation in another non-interventional drug or device study or registry is permitted.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Austria, Denmark, Finland, Germany, Spain, Sweden
Removed Location Countries	United States
Administrative Information
NCT Number	NCT01370629
Other Study ID Numbers	6621-049; EP01029.004 ( Other Identifier: Merck )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cardiome Pharma
Study Sponsor	Cardiome Pharma
Collaborators	Not Provided
Investigators	Not Provided
PRS Account	Cardiome Pharma
Verification Date	May 2018