Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, cardioversion
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.
Interventions
DRUGVernakalant
Prescribed at the discretion of the physician in accordance with their usual practice
Sponsors
Correvio International Sarl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| Number of Participants Experiencing Significant Bradycardia | Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Denmark, Finland, Germany, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings
Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice | 2,009 |
| Total | 2,009 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 985 Participants |
| Age, Categorical Between 18 and 65 years | 1024 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black | 5 Participants |
| Race/Ethnicity, Customized Race Hispanic | 6 Participants |
| Race/Ethnicity, Customized Race Other | 65 Participants |
| Race/Ethnicity, Customized Race White | 1931 Participants |
| Region of Enrollment Austria | 547 participants |
| Region of Enrollment Denmark | 113 participants |
| Region of Enrollment Finland | 256 participants |
| Region of Enrollment Germany | 300 participants |
| Region of Enrollment Spain | 300 participants |
| Region of Enrollment Sweden | 493 participants |
| Sex: Female, Male Female | 787 Participants |
| Sex: Female, Male Male | 1222 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,009 |
| other Total, other adverse events | 62 / 2,009 |
| serious Total, serious adverse events | 26 / 2,009 |
Outcome results
Primary
Number of Participants Experiencing Significant Atrial Flutter
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Experiencing Significant Atrial Flutter | 2 Participants |
Primary
Number of Participants Experiencing Significant Bradycardia
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Experiencing Significant Bradycardia | 15 Participants |
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
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Experiencing Significant Hypotension | 2 Participants |
Primary
Number of Participants Experiencing Significant Ventricular Arrhythmia
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Experiencing Significant Ventricular Arrhythmia | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute | 1359 Participants |