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| ID | Type | Description | Link |
|---|---|---|---|
| EP01029.004 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants treated with vernakalant IV in acute care and inpatient hospital settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vernakalant | Drug | Prescribed at the discretion of the physician in accordance with their usual practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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.
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Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitat Wien | Vienna | Austria | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion |
|
|
24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier
Health outcomes of interest (HOIs) were reported as defined in the study protocol section
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Significant hypotension | Cardiac disorders | Non-systematic Assessment | Significant hypotension defined as: symptomatic hypotension with systolic blood pressure (BP) <90 mmHg, requiring treatment with vasopressors |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Correvio International | +41 (0) 22 907 79 70 | info@correvio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2016 | Nov 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2018 | Nov 13, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C524581 | vernakalant |
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| Aalborg |
| Denmark |
| Kuopio Hospital | Kuopio | Finland |
| St-Vincenz Krankenhaus | Paderborn | Germany |
| Hospital Universitario Severo Ochoa | Madrid | Spain |
| Skanes Universistetssjukhus | Malmö | Sweden |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants Experiencing Significant Ventricular Arrhythmia | Posted | Count of Participants | Participants | Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion |
|
|
|
| Primary | Number of Participants Experiencing Significant Atrial Flutter | Posted | Count of Participants | Participants | Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion |
|
|
|
| Primary | Number of Participants Experiencing Significant Bradycardia | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Up to 90 minutes after the start (baseline) of first infusion of vernakalant |
|
|
|
| 0 |
| 2,009 |
| 26 |
| 2,009 |
| 62 |
| 2,009 |
|
| significant ventricular arrhythmia | Cardiac disorders | Non-systematic Assessment | Significant ventricular arrhythmia: Sustained VT with a ventricular heart rate >120 bpm >30 seconds or VT that required intervention or Torsade de Pointes with a duration of >10 seconds, or Ventricular fibrillation of any duration |
|
| Significant bradycardia | Cardiac disorders | Non-systematic Assessment | Significant bradycardia defined as: bradycardia requiring electrical pacing (temporary or permanent) or any other serious adverse event (SAE) reports involving bradycardia |
|
| Significant atrial flutter with 1:1 conduction | Cardiac disorders | Non-systematic Assessment | Significant atrial flutter (AFL) defined as: AFL with 1:1 atrioventricular conduction of >10 seconds duration and a ventricular rate of >200 bpm |
|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Non-sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Non-sustained wide QRS complex tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| Visual disturbance | Eye disorders | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |