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

Correvio Pharma

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Vernakalant

Study type: Observational

Funder types: Industry

Identifiers

NCT01370629

6621-049

EP01029.004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,015 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

2,015 participants in 1 patient group

All participants

Description:

Participants treated with vernakalant IV in acute care and inpatient hospital settings

Treatment:

Drug: Vernakalant