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Dronedarone in Atrial Fibrillation Post Ablation (EDORA)
NCT04704050Phase 4
Key facts
- Status
- Terminated
- Start
- May 2021
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Tulane University
- Modality
- Small Molecules
- Drugs
- dronedarone
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 4, randomised, double-blind trial of dronedarone in Atrial fibrillation (AFib) (2 arms), sponsored by Tulane University. Primary endpoints: Post-ablation Atrial Fibrillation Recurrence at 56 weeks and Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation at 56 weeks. Started May 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Treatment Group
Dronedarone 400 mg orally, twice per day (BID)
Control Group
Placebo tablet orally, twice per day (BID)
03
Who it enrols
Adults with paroxysmal or persistent atrial fibrillation undergoing ablation, excluding those with severe renal/hepatic impairment, specific cardiac contraindications, or MRI contraindications.
04
Endpoints
Primary
Post-ablation Atrial Fibrillation Recurrence
Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation
Secondary
Atrial Fibrillation Episodes
Repeat Cardiac Ablation
Cardioversion
Atrial Fibrillation Burden
Quality of Life
Incidence of Treatment-Emergent Adverse Events
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