Evidence map›Paper›PMID 24885377›Full record

Trial reportTrials2014

Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial.

Claudio Pragliola, Pasquale Mastroroberto, Mario Gaudino, Massimo Chello, Elvio Covino

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02968056 (One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT02968056 naunknown statusnot on this mapstarted 2016, after this paper: background citation

One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial

TypeinterventionalSponsorXinhua Hospital, Shanghai Jiao Tong University School of MedicineRan2016 to 2019Enrolled160ConditionsPersistent Atrial FibrillationArmsRadiofrequency ablation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Catheter Ablation in the Treatment of Atrial Fibrillation.The International journal of angiology : official publication of the International College of Angiology, Inc · 2020
    Article
  3. Review
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

5 authors at 4 institutions in 1 country.

Claudio PragliolaDipartimento di Scienze Cardiovascolari, Policlinico A Gemelli, Largo Gemelli 8, 00168 Roma, Italy. claudio.pragliola@libero.it.
Pasquale Mastroroberto
Mario Gaudino
Massimo Chello
Elvio Covino
Università Campus Bio-Medico · ITAgostino Gemelli University Polyclinic · ITMagna Graecia University · ITUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction. This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence. Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure. Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90% of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation. In this trial, we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation, followed by a second percutaneous procedure in case of recurrence, has a higher success rate than repeated percutaneous procedures. METHODS/

designThis is a controlled (2:1) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation. The inclusion and exclusion criteria, definitions, and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation. Patients will be randomized to either percutaneous catheter (n = 100) or surgical (n = 50) ablation as the first procedure. After 3 months, they are re-evaluated, according to the same guidelines, and receive a second procedure if necessary. Crossover will be allowed and data analyzed on an "intention-to-treat" basis. Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure. DISCUSSION: The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation.

trial registrationISRCTN08035058 Reg 06.20.2013.

Indexed as

Anti-Arrhythmia AgentsAnticoagulantsAtrial FibrillationCatheter AblationHumansMinimally Invasive Surgical ProceduresRecurrenceReoperationResearch DesignThoracotomyAnti-Arrhythmia AgentsAnticoagulants

Identifiers

PMID24885377
PMCPMC4066274
OpenAlexW1978953902

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.