Atrial FibrillationNCT01370629
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
An observational study of Atrial Fibrillation, run by Correvio International Sarl at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vernakalant
- Type of treatment
- Injection or infusion
- How many people
- 2,015 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Aug 2011to 8 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Vernakalant
- Keywords
- atrial fibrillation, cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VernakalantDrug
Also called BRINAVESS®
Prescribed at the discretion of the physician in accordance with their usual practice
| Study group | Role | What they receive |
|---|---|---|
| All participants | Participants treated with vernakalant IV in acute care and inpatient hospital settings Receives: Drug: Vernakalant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Significant Hypotension
Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) <90 mmHg, requiring treatment with vasopressors
Measured: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Ventricular Arrhythmia
Measured: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Atrial Flutter
Measured: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Bradycardia
Measured: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Secondary outcomes (1)
Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute
Measured: Up to 90 minutes after the start (baseline) of first infusion of vernakalant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startAug 2011
- Primary completion5 Apr 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Correvio International Sarl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370629
- Sponsor's protocol ID
- 6621-049
- Other IDs
- EP01029.004
- Status last verified
- Dec 2019
- First submitted
- 8 Jun 2011
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
- ClinicalTrials.gov ID
- NCT01370629
- Acronym / sponsor ID
- 6621-049
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, cardioversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,015 participants (actual)
- Lead sponsor
- Correvio International SarlIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: VernakalantParticipants treated with vernakalant IV in acute care and inpatient hospital settings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VernakalantAlso: BRINAVESS®Prescribed at the discretion of the physician in accordance with their usual practice | Drug | All participants |
Primary outcome
Number of Participants Experiencing Significant Hypotension
Time frame: 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
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Atrial Flutter
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Bradycardia
Time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Correvio International Sarl at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Denmark, Finland, Germany, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Significant Hypotension (time frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.