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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cardiome Pharma
Sponsor:
Information provided by (Responsible Party):
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT01370629
First received: June 8, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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 Intervention
Atrial Fibrillation
Drug: Vernakalant

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:
  • Number of participants experiencing significant hypotension [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing significant ventricular arrhythmia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing significant atrial flutter [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing significant bradycardia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®

  Eligibility

Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370629

Contacts
Contact: Steen Juul-Moller, Dr sjuul-moller@cardiome.com

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

No publications provided

Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01370629     History of Changes
Other Study ID Numbers: 6621-049, EP01029.004
Study First Received: June 8, 2011
Last Updated: March 20, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Cardiome Pharma:
atrial fibrillation
cardioversion

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

ClinicalTrials.gov processed this record on July 20, 2014