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

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ClinicalTrials.gov Identifier: NCT01370629
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiome Pharma

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Vernakalant

Study Type : Observational
Actual Enrollment : 2013 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
Study Start Date : August 2011
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : May 8, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All participants
Participants treated with vernakalant IV in acute care and inpatient hospital settings
Drug: Vernakalant
Prescribed at the discretion of the physician in accordance with their usual practice
Other Name: BRINAVESS®




Primary Outcome Measures :
  1. Number of participants experiencing significant hypotension [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]
  2. Number of participants experiencing significant ventricular arrhythmia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]
  3. Number of participants experiencing significant atrial flutter [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]
  4. Number of participants experiencing significant bradycardia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370629


Locations
Austria
Medizinische Universitat Wien
Vienna, Austria
Denmark
Aalborg, Denmark
Finland
Kuopio Hospital
Kuopio, Finland
Germany
St-Vincenz Krankenhaus
Paderborn, Germany
Spain
Hospital Universitario Severo Ochoa
Madrid, Spain
Sweden
Skanes Universistetssjukhus
Malmo, Sweden
Sponsors and Collaborators
Cardiome Pharma

Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01370629     History of Changes
Other Study ID Numbers: 6621-049
EP01029.004 ( Other Identifier: Merck )
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Cardiome Pharma:
atrial fibrillation
cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes