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Catheter ablation versus thoracoscopic surgical ablation in long standing persistent atrial fibrillation (CASA-AF): Study protocol for a randomised controlled trial

Catheter ablation versus thoracoscopic surgical ablation in long standing persistent atrial fibrillation (CASA-AF): Study protocol for a randomised controlled trial
Catheter ablation versus thoracoscopic surgical ablation in long standing persistent atrial fibrillation (CASA-AF): Study protocol for a randomised controlled trial

Background: Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. Methods/design: Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n = 120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ≥ 30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. Discussion: The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the comparative efficacy, safety and cost-effectiveness of thoracoscopic surgical ablation and conventional percutaneous catheter ablation for long-standing persistent atrial fibrillation. In addition, the results of the trial will provide information on the effects on patients' quality of life.

Catheter ablation, Implantable loop recorder, Left atrial appendage exclusion, Long-standing persistent atrial fibrillation, Randomised clinical trial, Thoracoscopic surgical ablation
1745-6215
Khan, Habib Rehman
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Kralj-Hans, Ines
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Haldar, Shouvik
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Bahrami, Toufan
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Clague, Jonathan
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De Souza, Anthony
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Francis, Darrel
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Hussain, Wajid
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Jarman, Julian
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Jones, David Gareth
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Mediratta, Neeraj
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Mohiaddin, Raad
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Salukhe, Tushar
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Jones, Simon
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Lord, Joanne
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Murphy, Caroline
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Kelly, Joanna
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Markides, Vias
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Gupta, Dhiraj
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Wong, Tom
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Khan, Habib Rehman
ef5e6248-435c-40ff-97f2-1bf0a759c43e
Kralj-Hans, Ines
51a276e5-d2f5-41d0-883b-83a9f230cd60
Haldar, Shouvik
6cc78f9a-8489-4881-92fc-57b3c2d231f2
Bahrami, Toufan
a5a71cb7-4464-40dc-aeae-c9c748363212
Clague, Jonathan
c8c668e7-393b-4e83-9d75-5b5cf7fc8816
De Souza, Anthony
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Francis, Darrel
293d11f6-c926-4d31-86e1-fb39c3eef47c
Hussain, Wajid
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Jarman, Julian
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Jones, David Gareth
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Mediratta, Neeraj
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Mohiaddin, Raad
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Salukhe, Tushar
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Jones, Simon
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Lord, Joanne
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Murphy, Caroline
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Kelly, Joanna
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Markides, Vias
271df9c2-26f7-4f1e-831e-bdb8e40f1a4a
Gupta, Dhiraj
63b39684-38ad-4a31-bf08-3805c665626a
Wong, Tom
d7ddec6a-c082-4ef2-b224-2c45a058b0fb

Khan, Habib Rehman, Kralj-Hans, Ines, Haldar, Shouvik, Bahrami, Toufan, Clague, Jonathan, De Souza, Anthony, Francis, Darrel, Hussain, Wajid, Jarman, Julian, Jones, David Gareth, Mediratta, Neeraj, Mohiaddin, Raad, Salukhe, Tushar, Jones, Simon, Lord, Joanne, Murphy, Caroline, Kelly, Joanna, Markides, Vias, Gupta, Dhiraj and Wong, Tom (2018) Catheter ablation versus thoracoscopic surgical ablation in long standing persistent atrial fibrillation (CASA-AF): Study protocol for a randomised controlled trial. Trials, 19 (1), [117]. (doi:10.1186/s13063-018-2487-9).

Record type: Article

Abstract

Background: Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. Methods/design: Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n = 120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ≥ 30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. Discussion: The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the comparative efficacy, safety and cost-effectiveness of thoracoscopic surgical ablation and conventional percutaneous catheter ablation for long-standing persistent atrial fibrillation. In addition, the results of the trial will provide information on the effects on patients' quality of life.

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Accepted/In Press date: 22 January 2018
e-pub ahead of print date: 20 February 2018
Keywords: Catheter ablation, Implantable loop recorder, Left atrial appendage exclusion, Long-standing persistent atrial fibrillation, Randomised clinical trial, Thoracoscopic surgical ablation

Identifiers

Local EPrints ID: 418427
URI: http://eprints.soton.ac.uk/id/eprint/418427
ISSN: 1745-6215
PURE UUID: 8f4180b0-acee-4b89-b85d-80a7afabd804
ORCID for Joanne Lord: ORCID iD orcid.org/0000-0003-1086-1624

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Date deposited: 08 Mar 2018 17:30
Last modified: 18 Mar 2024 03:32

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Contributors

Author: Habib Rehman Khan
Author: Ines Kralj-Hans
Author: Shouvik Haldar
Author: Toufan Bahrami
Author: Jonathan Clague
Author: Anthony De Souza
Author: Darrel Francis
Author: Wajid Hussain
Author: Julian Jarman
Author: David Gareth Jones
Author: Neeraj Mediratta
Author: Raad Mohiaddin
Author: Tushar Salukhe
Author: Simon Jones
Author: Joanne Lord ORCID iD
Author: Caroline Murphy
Author: Joanna Kelly
Author: Vias Markides
Author: Dhiraj Gupta
Author: Tom Wong

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