Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT01370629

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Drug: Vernakalant

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of participants experiencing significant hypotension [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant ventricular arrhythmia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant atrial flutter [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]
Number of participants experiencing significant bradycardia [ Time Frame: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All participants Participants treated with vernakalant IV in acute care and inpatient hospital settings	Drug: Vernakalant Prescribed at the discretion of the physician in accordance with their usual practice Other Name: BRINAVESS®

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370629

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Pennsylvania
Call for Information	Recruiting
North Wales, Pennsylvania, United States, 19454
Contact: Annie McNeill, M.D. 267-305-5545 annie.mcneill@merck.com

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01370629 History of Changes
Other Study ID Numbers:	6621-049
Study First Received:	June 8, 2011
Last Updated:	May 11, 2012
Health Authority:	European Union: European Medicines Agency

Keywords provided by Merck:

atrial fibrillation
cardioversion

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012