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Vernakalant Versus Flecainide: Atrial Contractility

NCT ID: NCT01646281

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

Brief Summary

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Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation Vernakalant Flecainide Echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Flecainide

Patients randomized to flecainide will receive a 10-minute infusion of 2 mg/kg (maximal 150 mg) flecainide. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.

Group Type ACTIVE_COMPARATOR

Flecainide

Intervention Type DRUG

10-minute infusion of 2 mg/kg (maximal 150 mg)

Vernakalant

Patients randomized to vernakalant will receive a 10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given. If the patient is still in AF 1 hour after the infusion, electrical cardioversion will be performed according to protocol.

Group Type ACTIVE_COMPARATOR

Vernakalant

Intervention Type DRUG

10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.

Interventions

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Vernakalant

10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.

Intervention Type DRUG

Flecainide

10-minute infusion of 2 mg/kg (maximal 150 mg)

Intervention Type DRUG

Other Intervention Names

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Brinavess, EV product code SUB30707 Tambocor, EV product code SUB13894MIG

Eligibility Criteria

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Inclusion Criteria

* persistent AF or paroxysmal AF
* eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm
* receiving adequate anticoagulant therapy (or having an episode of AF lasting \< 24 hours)

Exclusion Criteria

* refusal or inability to give informed consent to participate in this study
* atrial flutter
* contra-indications for receiving vernakalant or flecainide according to MUMC+ protocol (unstable hemodynamic condition, LVEF \< 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction)
* age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Crijns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Locations

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Maastricht University Hospital

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Ione Limantoro, MD

Role: CONTACT

Phone: +31433875119

Email: [email protected]

Harry Crijns, MD, PhD

Role: CONTACT

Phone: +31433875093

Email: [email protected]

Facility Contacts

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Ione Limantoro, MD

Role: primary

Harry Crijns, MD, PhD

Role: backup

Other Identifiers

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NL39854.068.12

Identifier Type: -

Identifier Source: org_study_id