Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study

Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology
Gerhard HindricksTom Wong

Abstract

The objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation procedure in a real-world clinical setting. The TRUE HD study enrolled patients undergoing catheter ablation with mapping for all arrhythmias (excluding de novo atrial fibrillation) who were followed for 1 month. Safety was determined by collecting all serious adverse events and adverse events associated with the study devices. Performance was determined as the composite of: ability to map the arrhythmia/substrate, complete the ablation applications, arrhythmia termination (where applicable), and ablation validation. Use of mapping system in the ablation validation workflow was also evaluated. Among the 519 patients who underwent a complete (504) or attempted (15) procedure, 21 (4%) serious ablation-related complications were collected, with 3 (0.57%) potentially related to the mapping catheter. Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% confidence interval: 79.8-86.5%). A total of 1419 electroanatomical maps were created with a median acquisition time of 9:23 min per map. Of ...Continue Reading

References

Jul 6, 2000·Pacing and Clinical Electrophysiology : PACE·M M Scheinman, S Huang
Apr 9, 2011·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Pasquale SantangeliAndrea Natale
Mar 7, 2012·Circulation. Arrhythmia and Electrophysiology·Hiroshi NakagawaWarren M Jackman
Feb 7, 2015·Pacing and Clinical Electrophysiology : PACE·Anees ThajudeenXunzhang Wang
Mar 31, 2015·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Sebastian HilbertAndreas Bollmann
Oct 13, 2015·Journal of Cardiovascular Electrophysiology·Andreas BollmannGerhard Hindricks
Jun 2, 2016·Journal of Cardiovascular Electrophysiology·Concepción Alonso-MartinXavier Viñolas
Nov 18, 2016·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Francesco SantoroAndreas Metzner
Nov 22, 2016·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Karthik ViswanathanTom Wong
Mar 31, 2017·Circulation. Arrhythmia and Electrophysiology·Vishal LutherPhang Boon Lim
Jun 24, 2017·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Ignacio García-BolaoEnrique Vives-Rodríguez
Aug 12, 2017·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Antonio FronteraNicolas Derval
Aug 24, 2017·Journal of Cardiovascular Electrophysiology·Arunashis SauD Wyn Davies
Sep 26, 2017·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Seigo YamashitaTeiichi Yamane

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Citations

Aug 11, 2019·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Kenneth M SteinTimothy M Stivland
Mar 25, 2021·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Elisabetta LapennaPaolo Della Bella
Apr 1, 2021··Zhihao JiangRenzhi Tang

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Clinical Trials Mentioned

NCT02698670

Software Mentioned

SAS
vMap

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