Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF)
CASA-AF
1 other identifier
interventional
120
1 country
3
Brief Summary
Atrial fibrillation (AF) is the most common heart arrhythmia. Many people do not have symptoms and are not aware they have AF. Others may feel dizzy, short of breath, feel very tired and become aware of a fast and irregular heart beat (palpitations). The main complication of AF is an increased risk of stroke and incidence of heart failure. There are two key aspects of treatment for AF. The first is protection from stroke, treated with oral anticoagulants. Treatment of AF is either by controlling the rate (frequency of contraction) or controlling the rhythm (restoring regular contraction). Rate-control is generally employed first with an intent to reduce the rate at which the lower pumping chambers contract and improve their efficiency. Appropriate medication is used and with this treatment strategy it is accepted that AF will be present as the long term heart rhythm. If symptoms persist despite medication the preferred strategy is to restore sinus rhythm (SR) and regular contraction in all pumping chambers of the heart. This can be done with electric shock treatment (DC cardioversion) together with long-term tablet medication, or by a more definitive 'cauterisation' therapy (catheter or thoracoscopic surgical ablation). In this study the investigators will study patients with symptomatic long standing persistent AF (continuous AF for more than 1 year) who have tried and failed drug and/or electrical therapy. At present the investigators do not know what the best ablation technique is for treating symptomatic, long-standing persistent AF (LSPAF). Catheter ablation (CA) is the most widely available invasive treatment available for AF. Thoracoscopic surgical ablation (SA) is not widely available but our hospitals have the expertise to conduct this procedure. CA has been shown to achieve modest degrees of success in restoring normal SR with the caveat that most patients do require 'multiple' procedures (usually two or three). SA offers patients an alternative choice of therapy with a keyhole surgical thoracoscopic) approach. It may have a higher single procedure success rate although there is the potential for greater complication rates. The investigators aim to examine this in detail to help us understand which approach might be better for managing LSPAF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedSeptember 12, 2019
September 1, 2019
4.4 years
April 18, 2016
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from atrial arrhythmias (>30 seconds) after a single procedure without anti-arrhythmic drugs (AADs) within 12 months measured by internal loop recorder
All patients will have internal loop recorder inserted after the completion of the procedure and the data will be analysed by a blinded core lab. 3 months of the blanking period will not be counted as accepted by EHRA / HRS committee. The definition of atrial arrhythmias is equal to or greater than 30 seconds of atrial tachycardia or atrial fibrillation as mentioned in EHRA / HRS consensus statement 2012.
12 months
Secondary Outcomes (10)
Intervention-related major complication rate defined as permanent injury or death, requires unplanned intervention for treatment, or prolongs or requires unplanned hospitalization for more than 48 hours
12 months
Clinical success from the arrhythmia interventions - defined as a 75% or greater reduction of AF burden with or without AADs.
12 months
Freedom from atrial arrhythmia, after multiple procedures without AADs
12 months
Changes in atrial anatomy and function following ablation as assessed by echocardiography using tissue Doppler and strain
12 months
Changes in atrial anatomy and atrial fibrosis following ablation as assessed by cardiac MRI
12 months
- +5 more secondary outcomes
Study Arms (2)
Thoracoscopic surgical ablation
EXPERIMENTALPulmonary vein isolation, ganglionic plexi ablation, left atrial appendage exclusion
Catheter ablation
ACTIVE COMPARATORPulmonary vein isolation, linear lines
Interventions
Thoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion
Ablation using contact force technology to isolate pulmonary veins and create linear lesions.
Eligibility Criteria
You may qualify if:
- Age≥ 18 yrs.
- LSPAF (\> 12 months' duration)
- EHRA\>2
- Left ventricular ejection fraction ≥ 40%
- Suitable for either ablation procedure
You may not qualify if:
- Left sided valvular heart disease with severity greater than mild
- Contraindication to anticoagulation
- Thrombus in the left atrium despite anticoagulation in therapeutic range
- Cerebrovascular accident within the previous 6 months
- Previous thoracic or cardiac surgery (including surgical interventions for AF)
- Prior left atrial catheter ablation for AF
- Unable to provide informed written consent
- Active malignancy, another severe concomitant condition or presence of implanted intracardiac devices that would preclude patient undergoing study specific procedures
- Pregnant or breast-feeding, or women of childbearing age not using a reliable contraceptive method.
- Implanted non MRI compatible cardiac devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Royal Brompton and Harefield Hospital NHS Trusts
London, SW36NP, United Kingdom
Related Publications (2)
Khan HR, Yakupoglu HY, Kralj-Hans I, Haldar S, Bahrami T, Clague J, De Souza A, Hussain W, Jarman J, Jones DG, Salukhe T, Markides V, Gupta D, Khattar R, Wong T; CASA AF Investigators. Left Atrial Function Predicts Atrial Arrhythmia Recurrence Following Ablation of Long-Standing Persistent Atrial Fibrillation. Circ Cardiovasc Imaging. 2023 Jun;16(6):e015352. doi: 10.1161/CIRCIMAGING.123.015352. Epub 2023 Jun 8.
PMID: 37288553DERIVEDHaldar S, Khan HR, Boyalla V, Kralj-Hans I, Jones S, Lord J, Onyimadu O, Satishkumar A, Bahrami T, De Souza A, Clague JR, Francis DP, Hussain W, Jarman JW, Jones DG, Chen Z, Mediratta N, Hyde J, Lewis M, Mohiaddin R, Salukhe TV, Murphy C, Kelly J, Khattar RS, Toff WD, Markides V, McCready J, Gupta D, Wong T. Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial. Eur Heart J. 2020 Dec 14;41(47):4471-4480. doi: 10.1093/eurheartj/ehaa658.
PMID: 32860414DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Wong
Royal Brompton & Harefield NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 29, 2016
Study Start
June 1, 2015
Primary Completion
October 30, 2019
Study Completion
March 31, 2020
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share