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OpenTrials
Completed

NCT Number: NCT01370629

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitat Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vernakalant

Drug

Prescribed at the discretion of the physician in accordance with their usual practice

Other names: BRINAVESS®

Primary outcomes

  1. 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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Correvio International Sarl

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2011
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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