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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370629
• Other study ID #: 6621-049
• Secondary ID: EP01029.004
• Status: Completed
• Start date: August 2011
• Est. completion date: May 8, 2018

Study information

• Verified date: December 2019
• Source: Correvio International Sarl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2015
• Est. completion date: May 8, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Vernakalant
Prescribed at the discretion of the physician in accordance with their usual practice

Locations

Country	Name	City	State
Austria	Medizinische Universitat Wien	Vienna
Finland	Kuopio Hospital	Kuopio
Germany	St-Vincenz Krankenhaus	Paderborn
Spain	Hospital Universitario Severo Ochoa	Madrid
Sweden	Skanes Universistetssjukhus	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Correvio International Sarl

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Significant Hypotension	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
Primary	Number of Participants Experiencing Significant Ventricular Arrhythmia		Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Primary	Number of Participants Experiencing Significant Atrial Flutter		Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Primary	Number of Participants Experiencing Significant Bradycardia		Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Secondary	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