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Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study

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Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study : Rationale and design of the international Cryo-FIRST study. / Hermida, Jean Sylvain; Chen, Jian; Meyer, Christian; Iacopino, Saverio; Arena, Giuseppe; Pavlovic, Nikola; Velagic, Vedran; Healey, Stewart; Packer, Douglas L; Pitschner, Heinz-Friedrich; de Asmundis, Carlo; Kuniss, Malte; Chierchia, Gian Battista.

in: AM HEART J, Jahrgang 222, 01.04.2020, S. 64-72.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Hermida, JS, Chen, J, Meyer, C, Iacopino, S, Arena, G, Pavlovic, N, Velagic, V, Healey, S, Packer, DL, Pitschner, H-F, de Asmundis, C, Kuniss, M & Chierchia, GB 2020, 'Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study: Rationale and design of the international Cryo-FIRST study', AM HEART J, Jg. 222, S. 64-72. https://doi.org/10.1016/j.ahj.2019.12.006

APA

Hermida, J. S., Chen, J., Meyer, C., Iacopino, S., Arena, G., Pavlovic, N., Velagic, V., Healey, S., Packer, D. L., Pitschner, H-F., de Asmundis, C., Kuniss, M., & Chierchia, G. B. (2020). Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study: Rationale and design of the international Cryo-FIRST study. AM HEART J, 222, 64-72. https://doi.org/10.1016/j.ahj.2019.12.006

Vancouver

Hermida JS, Chen J, Meyer C, Iacopino S, Arena G, Pavlovic N et al. Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study: Rationale and design of the international Cryo-FIRST study. AM HEART J. 2020 Apr 1;222:64-72. https://doi.org/10.1016/j.ahj.2019.12.006

Bibtex

@article{974e4f1f279f4349b730dfb64df52990,
title = "Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study: Rationale and design of the international Cryo-FIRST study",
abstract = "BACKGROUND: Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF.OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment na{\"i}ve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups.METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers.CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.",
keywords = "Ablation Techniques/methods, Anti-Arrhythmia Agents/therapeutic use, Atrial Fibrillation/physiopathology, Atrial Function, Right/physiology, Cryosurgery/methods, Electrocardiography, Female, Follow-Up Studies, Heart Conduction System/physiopathology, Humans, Male, Middle Aged, Prospective Studies, Pulmonary Veins/surgery, Quality of Life, Recurrence, Single-Blind Method, Treatment Outcome",
author = "Hermida, {Jean Sylvain} and Jian Chen and Christian Meyer and Saverio Iacopino and Giuseppe Arena and Nikola Pavlovic and Vedran Velagic and Stewart Healey and Packer, {Douglas L} and Heinz-Friedrich Pitschner and {de Asmundis}, Carlo and Malte Kuniss and Chierchia, {Gian Battista}",
note = "Copyright {\textcopyright} 2019 The Authors. Published by Elsevier Inc. All rights reserved.",
year = "2020",
month = apr,
day = "1",
doi = "10.1016/j.ahj.2019.12.006",
language = "English",
volume = "222",
pages = "64--72",
journal = "AM HEART J",
issn = "0002-8703",
publisher = "Mosby Inc.",

}

RIS

TY - JOUR

T1 - Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study

T2 - Rationale and design of the international Cryo-FIRST study

AU - Hermida, Jean Sylvain

AU - Chen, Jian

AU - Meyer, Christian

AU - Iacopino, Saverio

AU - Arena, Giuseppe

AU - Pavlovic, Nikola

AU - Velagic, Vedran

AU - Healey, Stewart

AU - Packer, Douglas L

AU - Pitschner, Heinz-Friedrich

AU - de Asmundis, Carlo

AU - Kuniss, Malte

AU - Chierchia, Gian Battista

N1 - Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2020/4/1

Y1 - 2020/4/1

N2 - BACKGROUND: Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF.OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups.METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers.CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.

AB - BACKGROUND: Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF.OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups.METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers.CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.

KW - Ablation Techniques/methods

KW - Anti-Arrhythmia Agents/therapeutic use

KW - Atrial Fibrillation/physiopathology

KW - Atrial Function, Right/physiology

KW - Cryosurgery/methods

KW - Electrocardiography

KW - Female

KW - Follow-Up Studies

KW - Heart Conduction System/physiopathology

KW - Humans

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Pulmonary Veins/surgery

KW - Quality of Life

KW - Recurrence

KW - Single-Blind Method

KW - Treatment Outcome

U2 - 10.1016/j.ahj.2019.12.006

DO - 10.1016/j.ahj.2019.12.006

M3 - SCORING: Journal article

C2 - 32018203

VL - 222

SP - 64

EP - 72

JO - AM HEART J

JF - AM HEART J

SN - 0002-8703

ER -