Evidence map›Paper›PMID 34664772›Full record

ArticleJournal of cardiovascular electrophysiology2021

Effect of DrOnedarone on atrial fibrosis progression and atrial fibrillation recurrence postablation: Design of the EDORA randomized clinical trial.

Nassir F Marrouche, Lilas Dagher, Oussama Wazni, Nazem Akoum, Moussa Mansour, Abdel Hadi El Hajjar, Arezu Bhatnagar, He Hua, EDORA Investigators

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of cardiovascular electrophysiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04704050 (Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04704050 phase4terminatednot on this map

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation: The EDORA Trial

TypeinterventionalSponsorTulane University School of MedicineRan2021 to 2022Enrolled22ConditionsAtrial Fibrillation, Atrial Fibrillation RecurrentArmsdronedarone 400 mg Oral Tablet, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Nassir F MarroucheDepartment of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.ORCID 0000-0003-0454-0541
Lilas DagherDepartment of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.ORCID 0000-0003-0660-318X
Oussama WazniDepartment of Cardiac Electrophysiology, Cleveland Clinic, Cleveland, Ohio, USA.
Nazem AkoumDepartment of Cardiology, University of Washington Medical Center, Seattle, Washington, USA.ORCID 0000-0002-2001-6806
Moussa MansourDepartment of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Abdel Hadi El HajjarDepartment of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.ORCID 0000-0003-4820-8102
Arezu BhatnagarDepartment of Cardiology, Tulane University School of Medicine, New Orleans, Los Angeles, USA.
He HuaDepartment of Epidemiology, Tulane University School of Public Health, New Orleans, Los Angeles, USA.
EDORA Investigators
Tulane University · USCleveland Clinic · USMassachusetts General Hospital · USUniversity of Washington Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtrial fibrillation (AF) recurrence after catheter ablation is associated with worse outcomes and quality of life. Left atrial (LA) structural remodeling provides the essential substrate for AF perpetuation. Baseline extent and the progression of LA fibrosis after ablation are strong predictors of postprocedural AF recurrence. Dronedarone is an antiarrhythmic drug proven to efficiently maintain sinus rhythm.

objectiveWe sought to investigate the effect of the antiarrhythmic drug Dronedarone in decreasing LA fibrosis progression and AF recurrence after ablation of AF patients.

methodsEDORA (NCT04704050) is a multicenter, prospective, randomized controlled clinical trial. Patients with persistent or paroxysmal AF undergoing AF ablation will be randomized into Dronedarone versus placebo/standard of care. The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation. All patients will receive a late-gadolinium enhancement magnetic resonance imaging at baseline, 3- and 12-month follow-up for the quantification of LA fibrosis and ablation-related scarring. AA recurrence and burden will be assessed using a 30-day ECG patch every 3 months with daily ECG recordings in between. Quality of life improvement is assessed using the AFEQT and AFSS questionnaires.

conclusionEDORA will be the first trial to assess the progression of LA structural remodeling after ablation and its association with Dronedarone treatment and ablation success in a randomized controlled fashion. The trial will provide insight into the pathophysiology of AF recurrence after ablation and may provide potential therapeutic targets to optimize procedural outcomes.

Indexed as

Atrial FibrillationCatheter AblationContrast MediaDronedaroneFibrosisGadoliniumHeart AtriaHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRecurrenceTreatment OutcomeContrast MediaDronedaroneGadoliniumablationatrial fibrillationdronedaronefibrosis

Identifiers

PMID34664772
PMCPMC9298087
OpenAlexW3207051113

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.