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

Correvio International Sarl2,015 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,015

Conditions

Atrial Fibrillation

Interventions

VernakalantDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (6)

Medizinische Universitat Wien

Vienna, Austria

Unnamed facility

Aalborg, Denmark

Kuopio Hospital

Kuopio, Finland

St-Vincenz Krankenhaus

Paderborn, Germany

Hospital Universitario Severo Ochoa

Outcomes

Primary Outcomes

Number of Participants Experiencing Significant Hypotension

Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) \<90 mmHg, requiring treatment with vasopressors

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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