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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Vernakalant

• Registration Number: NCT01370629
• Lead Sponsor: Correvio International Sarl

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Start: 2011-08
• Primary Completion: 2018-04-05
• Study Completion: 2018-05-08
• Results First Submitted: 2019-11-13
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2015

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Vernakalant	Participants treated with vernakalant IV in acute care and inpatient hospital settings

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Significant Hypotension	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
Number of Participants Experiencing Significant Bradycardia	Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Ventricular Arrhythmia	Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Atrial Flutter	Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute	Up to 90 minutes after the start (baseline) of first infusion of vernakalant

Trial Locations

Locations (5)

St-Vincenz Krankenhaus; 🇩🇪 Paderborn, Germany

Hospital Universitario Severo Ochoa; 🇪🇸 Madrid, Spain

Skanes Universistetssjukhus; 🇸🇪 Malmo, Sweden

Kuopio Hospital; 🇫🇮 Kuopio, Finland

Medizinische Universitat Wien; 🇦🇹 Vienna, Austria