Persistent Atrial FibrillationCASA-AFNCT02755688
Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF)
A study testing Thoracoscopic Surgical ablation and Catheter ablation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Thoracoscopic Surgical ablation and Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jun 2015to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 yrs.
- LSPAF (> 12 months' duration)
- EHRA>2
- Left ventricular ejection fraction ≥ 40%
- Suitable for either ablation procedure
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
Liverpool Heart and Chest Hospital
Liverpool
Royal Brompton and Harefield Hospital NHS Trusts
London, SW36NP
About this study
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.
Read the detailed description
This is a multi-center randomised controlled study of catheter ablation compared with totally thoracoscopic surgical ablation.
The study population will be patients above the age of 18 with symptomatic long-standing persistent atrial fibrillation (≥1≤5 years) and good left ventricular function where at least one anti-arrhythmic drug (AAD) has failed, or where such drugs are contraindicated or not tolerated.
Subjects randomised to thoracoscopic Surgical Ablation will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. Posterior wall will be isolated in a box fashion with cool rail bipolar RF device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation Group Patients will undergo pulmonary vein isolation and linear ablations in the left and right atrium.
There will be a 3 month blanking period and symptomatic atrial arrhythmia may have catheter ablation during the period of 12 month follow up. The primary end point of the study will be assessed by continuous cardiac recording through an internal loop recorder that will be inserted at the end of the index procedure. The analysis and reporting of the recordings will be performed by a blinded core lab.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Thoracoscopic Surgical ablation, Catheter ablation
- Keywords
- atrial fibrillation, catheter ablation, thoracoscopic surgical ablation, long standing persistent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic Surgical ablationProcedure or surgery
Thoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion
Catheter ablationProcedure or surgery
Ablation using contact force technology to isolate pulmonary veins and create linear lesions.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic surgical ablation | Experimental | Pulmonary vein isolation, ganglionic plexi ablation, left atrial appendage exclusion Receives: Procedure: Thoracoscopic Surgical ablation |
| Catheter ablation | Active comparator | Pulmonary vein isolation, linear lines Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Clinical success from the arrhythmia interventions - defined as a 75% or greater reduction of AF burden with or without AADs.
Measured: 12 months
Freedom from atrial arrhythmia, after multiple procedures without AADs
Measured by internal loop recorder and analysed by blinded core lab.
Measured: 12 months
Changes in atrial anatomy and function following ablation as assessed by echocardiography using tissue Doppler and strain
Measured: 12 months
Changes in atrial anatomy and atrial fibrosis following ablation as assessed by cardiac MRI
Measured: 12 months
Effects of the arrhythmia interventions on the patients' symptoms by Change in AF symptom score (EHRA score)
Measured: 12 months
Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (EQ5D)
Measured: 12 months
Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (AFEQT)
Measured: 12 months
Quality Adjusted Life Years (QALYs) accrued during follow up
Measured: 12 months
Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJun 2015
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tom Wong, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755688
- Sponsor's protocol ID
- 2014CI005B
- Acronym
- CASA-AF
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37288553Haldar 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.
PubMed 32860414
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF)
- ClinicalTrials.gov ID
- NCT02755688
- Acronym / sponsor ID
- CASA-AF / 2014CI005B
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, thoracoscopic surgical ablation, long standing persistent atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- Jun 2015
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center randomised controlled study of catheter ablation compared with totally thoracoscopic surgical ablation.
The study population will be patients above the age of 18 with symptomatic long-standing persistent atrial fibrillation (≥1≤5 years) and good left ventricular function where at least one anti-arrhythmic drug (AAD) has failed, or where such drugs are contraindicated or not tolerated.
Subjects randomised to thoracoscopic Surgical Ablation will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. Posterior wall will be isolated in a box fashion with cool rail bipolar RF device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation Group Patients will undergo pulmonary vein isolation and linear ablations in the left and right atrium.
There will be a 3 month blanking period and symptomatic atrial arrhythmia may have catheter ablation during the period of 12 month follow up. The primary end point of the study will be assessed by continuous cardiac recording through an internal loop recorder that will be inserted at the end of the index procedure. The analysis and reporting of the recordings will be performed by a blinded core lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic surgical ablation | Experimental | Procedure: Thoracoscopic Surgical ablationPulmonary vein isolation, ganglionic plexi ablation, left atrial appendage exclusion |
| Catheter ablation | Active comparator | Procedure: Catheter ablationPulmonary vein isolation, linear lines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥ 18 yrs.
- LSPAF (> 12 months' duration)
- EHRA>2
- Left ventricular ejection fraction ≥ 40%
- Suitable for either ablation procedure
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracoscopic Surgical ablationThoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion | Procedure or surgery | Thoracoscopic surgical ablation |
| Catheter ablationAblation using contact force technology to isolate pulmonary veins and create linear lesions. | Procedure or surgery | Catheter ablation |
Primary outcome
Freedom from atrial arrhythmias (>30 seconds) after a single procedure without anti-arrhythmic drugs (AADs) within 12 months measured by internal loop recorder
Time frame: 12 months
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.
10 secondary outcomes
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
Time frame: 12 months
Clinical success from the arrhythmia interventions - defined as a 75% or greater reduction of AF burden with or without AADs.
Time frame: 12 months
Freedom from atrial arrhythmia, after multiple procedures without AADs
Time frame: 12 months
Changes in atrial anatomy and function following ablation as assessed by echocardiography using tissue Doppler and strain
Time frame: 12 months
Changes in atrial anatomy and atrial fibrosis following ablation as assessed by cardiac MRI
Time frame: 12 months
Effects of the arrhythmia interventions on the patients' symptoms by Change in AF symptom score (EHRA score)
Time frame: 12 months
Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (EQ5D)
Time frame: 12 months
Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (AFEQT)
Time frame: 12 months
Quality Adjusted Life Years (QALYs) accrued during follow up
Time frame: 12 months
Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 37288553Khan 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.
- Derived from this study: PubMed 32860414Haldar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Wong principal investigator
Royal Brompton & Harefield NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopic Surgical ablation and Catheter ablation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial arrhythmias (>30 seconds) after a single procedure without anti-arrhythmic drugs (AADs) within 12 months measured by internal loop recorder (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755688, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.