NCT01370629

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 30, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

6.7 years

First QC Date

June 8, 2011

Results QC Date

November 13, 2019

Last Update Submit

December 12, 2019

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcardioversion

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

All participants

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

Drug: Vernakalant

Interventions

VernakalantDRUG

Prescribed at the discretion of the physician in accordance with their usual practice

Also known as: BRINAVESS®
All participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants treated with intravenous vernakalant in acute care and inpatient hospital settings per usual care

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medizinische Universitat Wien

Vienna, Austria

Location

Unknown Facility

Aalborg, Denmark

Location

Kuopio Hospital

Kuopio, Finland

Location

St-Vincenz Krankenhaus

Paderborn, Germany

Location

Hospital Universitario Severo Ochoa

Madrid, Spain

Location

Skanes Universistetssjukhus

Malmo, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

vernakalant

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Head of Clinical Development
Organization
Correvio International
info@correvio.com
+41 (0) 22 907 79 70

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 10, 2011

Study Start

August 1, 2011

Primary Completion

April 5, 2018

Study Completion

May 8, 2018

Last Updated

December 30, 2019

Results First Posted

December 30, 2019

Record last verified: 2019-12

Locations

AU(1)ES(1)SE(1)DK(1)FI(1)DE(1)