Study design of the man and machine trial: A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation

Andreas Rillig, Boris Schmidt, Daniel Steven, Udo Meyerfeldt, Luigi Di Biase, Erik Wissner, Rüdiger Becker, Dierk Thomas, Peter Wohlmuth, G. Joseph Gallinghouse, Eberhardt Scholz, Werner Jung, Stefan Willems, Andrea Natale, Feifan Ouyang, Karl Heinz Kuck, Roland Tilz

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug-resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation. Methods: In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short-standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12-month follow-up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure. Conclusion: The "Man and Machine Trial" is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12-month follow-up period.

Original languageEnglish (US)
Pages (from-to)40-46
Number of pages7
JournalJournal of Cardiovascular Electrophysiology
Volume24
Issue number1
DOIs
StatePublished - Jan 2013
Externally publishedYes

Fingerprint

Catheter Ablation
Robotics
Atrial Fibrillation
Pulmonary Veins
Catheters
Multicenter Studies
Ablation Techniques
Safety
Anti-Arrhythmia Agents
Fluoroscopy
Therapeutics
Tachycardia
Endoscopy
Drug Therapy
Incidence
Wounds and Injuries
Pharmaceutical Preparations

Keywords

  • atrial fibrillation
  • catheter ablation
  • pulmonary vein isolation
  • randomized clinical trial
  • robotics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Study design of the man and machine trial : A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation. / Rillig, Andreas; Schmidt, Boris; Steven, Daniel; Meyerfeldt, Udo; Di Biase, Luigi; Wissner, Erik; Becker, Rüdiger; Thomas, Dierk; Wohlmuth, Peter; Gallinghouse, G. Joseph; Scholz, Eberhardt; Jung, Werner; Willems, Stefan; Natale, Andrea; Ouyang, Feifan; Kuck, Karl Heinz; Tilz, Roland.

In: Journal of Cardiovascular Electrophysiology, Vol. 24, No. 1, 01.2013, p. 40-46.

Research output: Contribution to journalArticle

Rillig, A, Schmidt, B, Steven, D, Meyerfeldt, U, Di Biase, L, Wissner, E, Becker, R, Thomas, D, Wohlmuth, P, Gallinghouse, GJ, Scholz, E, Jung, W, Willems, S, Natale, A, Ouyang, F, Kuck, KH & Tilz, R 2013, 'Study design of the man and machine trial: A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation', Journal of Cardiovascular Electrophysiology, vol. 24, no. 1, pp. 40-46. https://doi.org/10.1111/j.1540-8167.2012.02418.x
Rillig, Andreas ; Schmidt, Boris ; Steven, Daniel ; Meyerfeldt, Udo ; Di Biase, Luigi ; Wissner, Erik ; Becker, Rüdiger ; Thomas, Dierk ; Wohlmuth, Peter ; Gallinghouse, G. Joseph ; Scholz, Eberhardt ; Jung, Werner ; Willems, Stefan ; Natale, Andrea ; Ouyang, Feifan ; Kuck, Karl Heinz ; Tilz, Roland. / Study design of the man and machine trial : A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation. In: Journal of Cardiovascular Electrophysiology. 2013 ; Vol. 24, No. 1. pp. 40-46.
@article{19d994efe9e746088c1bf91741a20ad9,
title = "Study design of the man and machine trial: A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation",
abstract = "Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug-resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation. Methods: In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short-standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12-month follow-up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure. Conclusion: The {"}Man and Machine Trial{"} is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12-month follow-up period.",
keywords = "atrial fibrillation, catheter ablation, pulmonary vein isolation, randomized clinical trial, robotics",
author = "Andreas Rillig and Boris Schmidt and Daniel Steven and Udo Meyerfeldt and {Di Biase}, Luigi and Erik Wissner and R{\"u}diger Becker and Dierk Thomas and Peter Wohlmuth and Gallinghouse, {G. Joseph} and Eberhardt Scholz and Werner Jung and Stefan Willems and Andrea Natale and Feifan Ouyang and Kuck, {Karl Heinz} and Roland Tilz",
year = "2013",
month = "1",
doi = "10.1111/j.1540-8167.2012.02418.x",
language = "English (US)",
volume = "24",
pages = "40--46",
journal = "Journal of Cardiovascular Electrophysiology",
issn = "1045-3873",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - Study design of the man and machine trial

T2 - A prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation

AU - Rillig, Andreas

AU - Schmidt, Boris

AU - Steven, Daniel

AU - Meyerfeldt, Udo

AU - Di Biase, Luigi

AU - Wissner, Erik

AU - Becker, Rüdiger

AU - Thomas, Dierk

AU - Wohlmuth, Peter

AU - Gallinghouse, G. Joseph

AU - Scholz, Eberhardt

AU - Jung, Werner

AU - Willems, Stefan

AU - Natale, Andrea

AU - Ouyang, Feifan

AU - Kuck, Karl Heinz

AU - Tilz, Roland

PY - 2013/1

Y1 - 2013/1

N2 - Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug-resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation. Methods: In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short-standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12-month follow-up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure. Conclusion: The "Man and Machine Trial" is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12-month follow-up period.

AB - Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug-resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation. Methods: In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short-standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12-month follow-up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure. Conclusion: The "Man and Machine Trial" is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12-month follow-up period.

KW - atrial fibrillation

KW - catheter ablation

KW - pulmonary vein isolation

KW - randomized clinical trial

KW - robotics

UR - http://www.scopus.com/inward/record.url?scp=84871989398&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84871989398&partnerID=8YFLogxK

U2 - 10.1111/j.1540-8167.2012.02418.x

DO - 10.1111/j.1540-8167.2012.02418.x

M3 - Article

C2 - 23131063

AN - SCOPUS:84871989398

VL - 24

SP - 40

EP - 46

JO - Journal of Cardiovascular Electrophysiology

JF - Journal of Cardiovascular Electrophysiology

SN - 1045-3873

IS - 1

ER -