N/A
N=2,015
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01370629 ↗Enrolled (actual)
2,015
Serious AEs
1.3%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants Experiencing Significant Hypotension — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vernakalant (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Correvio International Sarl
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Significant Hypotension |
2 | — |
| PRIMARY Number of Participants Experiencing Significant Ventricular Arrhythmia |
1 | — |
| PRIMARY Number of Participants Experiencing Significant Atrial Flutter |
2 | — |
| PRIMARY Number of Participants Experiencing Significant Bradycardia |
15 | — |
| SECONDARY Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute |
1359 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01370629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.