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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

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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: J CARDIOVASC ELECTR, Vol. 24, No. 1, 01.2013, p. 40-46.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

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', J CARDIOVASC ELECTR, vol. 24, no. 1, pp. 40-46. https://doi.org/10.1111/j.1540-8167.2012.02418.x

APA

Rillig, A., Schmidt, B., Steven, D., Meyerfeldt, U., DI Biase, L., Wissner, E., Becker, R., Thomas, D., Wohlmuth, P., Gallinghouse, G. J., Scholz, E., Jung, W., Willems, S., Natale, A., Ouyang, F., Kuck, K. H., & 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. J CARDIOVASC ELECTR, 24(1), 40-46. https://doi.org/10.1111/j.1540-8167.2012.02418.x

Vancouver

Rillig A, Schmidt B, Steven D, Meyerfeldt U, DI Biase L, Wissner E et al. 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. J CARDIOVASC ELECTR. 2013 Jan;24(1):40-46. https://doi.org/10.1111/j.1540-8167.2012.02418.x

Bibtex

@article{9225f014a7ea4e6ca73d523be55b574c,
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 = "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 = "Adult, Aged, Atrial Fibrillation/surgery, Catheter Ablation/methods, Female, Humans, Internationality, Male, Middle Aged, Prospective Studies, Research Design, Robotics/methods, Surgery, Computer-Assisted/methods, Treatment Outcome",
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",
note = "{\textcopyright} 2012 Wiley Periodicals, Inc.",
year = "2013",
month = jan,
doi = "10.1111/j.1540-8167.2012.02418.x",
language = "English",
volume = "24",
pages = "40--46",
journal = "J CARDIOVASC ELECTR",
issn = "1045-3873",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - 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

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

N1 - © 2012 Wiley Periodicals, Inc.

PY - 2013/1

Y1 - 2013/1

N2 - 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 - 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 - Adult

KW - Aged

KW - Atrial Fibrillation/surgery

KW - Catheter Ablation/methods

KW - Female

KW - Humans

KW - Internationality

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Research Design

KW - Robotics/methods

KW - Surgery, Computer-Assisted/methods

KW - Treatment Outcome

U2 - 10.1111/j.1540-8167.2012.02418.x

DO - 10.1111/j.1540-8167.2012.02418.x

M3 - SCORING: Journal article

C2 - 23131063

VL - 24

SP - 40

EP - 46

JO - J CARDIOVASC ELECTR

JF - J CARDIOVASC ELECTR

SN - 1045-3873

IS - 1

ER -