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Evaluation of Cardioverter Capacity of Amiodarone Pre-electrical Cardioversion in Persistent Atrial Fibrillation

ConditionAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

Phase: IV Population: Sample size= 122 patients; male and female; ≥ 18 y.o.; patients with persistent atrial fibrillation referred for electrical cardioversion; performed in Spain Number of Sites: 4 Study Duration: 15/10/2024 - 15/5/2026 Subject Participation Duration: 2-4 months (depending on the arm) Description of Agent or Intervention: amiodarone

Objectives:

Primary: To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen Secondary: 1) Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; 2) To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen

Description of Study Design: Multicenter randomized open clinical trial. 122 Patients with persistent AF (≥7 days duration) electively referred for CVE will be included. Two amiodarone regimens administered pre-CVE will be compared evaluating their cardioverter efficacy. Patients will be randomized to 2 groups:

1. Treatment impregnation with amiodarone starting one month before ECV (600 mg/day 1st week, 400 mg/day 2nd week and 200 mg/day thereafter until ECV). 2. Treatment impregnation with amiodarone 800 mg/day started 5 days before ECV. Estimated Time to Complete Enrollment: 13 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years old.

Persistent atrial fibrillation (≥ 7 days duration).

Referred for elective electrical cardioversion.

Signing of the informed consent

Disqualifiers

Need of urgent electrical cardioversion

Mean Heart rate <50 bpm

Planned ablation < 1 month after ECV.

Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amiodarone (Antiarrhythmic drug)

    Drug

    Comparing 2 regimes of amiodarone pre-electrical cardioversion witn ECG monitoring

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Amiodarone orally impregnation starting one month before ECVExperimental treatment 1 intervention
Group B: Amiodarone orally impregnation started 5 days before ECVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reversal to sinus rhythm pre-electrical cardioversion

Number of patients who revert to sinus rhythm before electrical cardioversion

Time frame
From date of enrollment until the date of electrical cardioversion, up to 8 weeks

Secondary outcomes

1

Days until reversal to sinus rhythm

Number of days from enrollment to reversion to sinus rhythm

Time frame
From date of enrollment until date of electrical cardioversion, up to 8 weeks
2

Maintenance of sinus rhythm at 1 month after cardioversion

Number of patients who remain in sinus rhythm at 1 month after reversion to sinus rhythm (pharmacological or electrical)

Time frame
From date of reversion to sinus rhythm until 1 month later

Other outcomes

Sponsors and contacts

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Institut Investigacio Sanitaria Pere Virgili

Lead sponsor

Spanish Society of Cardiology

Collaborator

Sociedad Espanola de Cardiologia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: