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

December 12, 2019 updated by: Correvio International Sarl

A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2015

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medizinische Universität Wien
  • Denmark
      • Aalborg, Denmark
  • Finland
      • Kuopio, Finland
        • Kuopio Hospital
  • Germany
      • Paderborn, Germany
        • St-Vincenz Krankenhaus
  • Spain
      • Madrid, Spain
        • Hospital Universitario Severo Ochoa
  • Sweden
      • Malmo, Sweden
        • Skanes Universistetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • BRINAVESS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Significant Hypotension
Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) <90 mmHg, requiring treatment with vasopressors
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
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
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
Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 90 minutes after the start (baseline) of first infusion of vernakalant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Correvio International Sarl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

May 8, 2018

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6621-049
  • EP01029.004 (Other Identifier: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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