Persistent Atrial FibrillationCASA-AFNCT01385358
Catheter Versus Thoracoscopic Surgical Ablation Strategy in Persistent Atrial Fibrillation
A study testing Thoracoscopically Assisted Surgical Ablation and Catheter Ablation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant morbidity and mortality, posing an increasing public health burden. Restoration of sinus rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with anti-arrhythmic drugs (AAD) are poor. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Thoracoscopically Assisted 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
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Oct 2013
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤ 80
- Symptomatic persistent AF (≥1≤5 years), refractory to at least 1 AAD and/or DCCV
- Patient is legally competent and willing and able to sign informed consent form
- Patient is willing and able to adhere to follow up visit protocols for the duration of the study
Who cannot join
- Left ventricular ejection fraction < 40%
- Cardiovascular implantable electronic device (contraindicates MRI imaging)
- Contraindication to anticoagulation
- Thrombus in the LA despite anticoagulation
- CVA within the previous 6 months
- Previous thoracic \& cardiac surgery (including interventions for AF such as Cox-maze procedure)
Show all 10Show fewer
- Prior LA catheter ablation with the intention to treat AF
- Prior AV nodal ablation
- Patients actively participating in another research study will be not be permitted to enrol. Patients who have been involved with other research studies will be able to participate after a minimum period of 3 months after completion of prior study follow up.
- Co-morbid condition that in opinion of investigator confers undue risk of GA or thoracoscopic surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS Foundation Trust
London, Greater London, SW3 6NP
About this study
Official title: A Study to Assess Catheter Ablation Versus Thoracoscopically Assisted Surgical Ablation in Persistent Atrial Fibrillation
Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant morbidity and mortality, posing an increasing public health burden. Restoration of sinus rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions' to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions are made in the atria to restore SR. Long term results from this traditional surgical approach are excellent however as it is technically difficult open-heart procedure with significant morbidity and mortality, it is seldom used.
CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a more persistent or permanent state and becomes more difficult to treat with CA. Therefore, the optimum approach to treat patients with symptomatic long standing persistent AF has yet to be determined and remains a key area of on-going research.
Read more
New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have recently developed which ablate a wide area around the pulmonary veins, and may offer advantages over the best current strategies in CA. There are also clear advantages for patients with greater safety and less discomfort when compared to traditional surgical open-heart procedures.
At present there is small amount of encouraging data on this thoracoscopic surgical technique but there is no data comparing these two modalities of treatment in persistent AF patients. The investigators therefore wish to prospectively investigate the safety and efficacy of this thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning will also be used to visualise the effects of ablation by analysis of scar formation.
The study hypothesises that thoracoscopics surgical ablation is a
Read the detailed description
This will be a pilot, prospective, observational study of catheter ablation compared with thoracoscopically assisted, surgical ablation strategies using a case control design.
The study population will be patients between the ages of 18 and 80 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.
Thoracoscopically Assisted Surgical Ablation Group Patients assigned to this group will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation Group Patients will undergo pulmonary vein isolation, linear and electrogram based ablation.
Recurrences Only one redo procedure is allowed for atrial tachyarrhythmia recurrences in the 12 month follow-up period.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Thoracoscopically Assisted Surgical Ablation, Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopically Assisted Surgical AblationProcedure or surgery
Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.
Catheter AblationProcedure or surgery
In this arm, study subjects will undergo conventional catheter ablation as their index procedure. This will include pulmonary vein isolation, linear and electrogram based ablation.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopically Assisted Surgical Ablation | Experimental | This arm will have an index thoracoscopically assisted surgical ablation. Receives: Procedure: Thoracoscopically Assisted Surgical Ablation |
| Catheter Ablation | Active comparator | This is an active comparator arm where study subjects will undergo conventional catheter ablation. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial tachyarrhythmias at 12 months.
Freedom from atrial tachyarrhythmias at 12 months which will be analysed with or without anti-arrhythmic drugs (AAD). Monitoring will be undertaken with ambulatory ECG monitoring in compliance with latest international guidelines.
Measured: 12 months
Secondary outcomes (5)
Freedom from atrial tachyarrhythmias at 12 months from a single procedure on/off AAD;
Only 1 re-do procedure is allowed in study time frame. But this outcome will look at single procedure success in both arms at 12 months.
Measured: 12 months
Change in AF symptom score
Using recognised AF symptom score scale
Measured: Various time points 0,3,6,9,12 months
Integrity of ablation lesion after index procedure at 3 months (as assessed by MRI if in SR +/- electrophysiologically if redo procedure is undertaken for atrial arrhythmia recurrence);
Using MRI +/- electrophysiological techniques.
Measured: 3 months
Freedom of serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up.
Measured: 12 months
Cost analysis (procedural and hospital stay costs).
Top down cost analysis
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 posted30 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Tom Wong, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385358
- Sponsor's protocol ID
- 2011CI004B
- Other IDs
- 11/SC/0032
- Acronym
- CASA-AF
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Catheter Ablation Versus Thoracoscopically Assisted Surgical Ablation in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01385358
- Acronym / sponsor ID
- CASA-AF / 2011CI004B
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 30 Jun 2011 (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 commonest arrhythmia worldwide and can lead to significant morbidity and mortality, posing an increasing public health burden. Restoration of sinus rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions' to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions are made in the atria to restore SR. Long term results from this traditional surgical approach are excellent however as it is technically difficult open-heart procedure with significant morbidity and mortality, it is seldom used.
CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a more persistent or permanent state and becomes more difficult to treat with CA. Therefore, the optimum approach to treat patients with symptomatic long standing persistent AF has yet to be determined and remains a key area of on-going research.
New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have recently developed which ablate a wide area around the pulmonary veins, and may offer advantages over the best current strategies in CA. There are also clear advantages for patients with greater safety and less discomfort when compared to traditional surgical open-heart procedures.
At present there is small amount of encouraging data on this thoracoscopic surgical technique but there is no data comparing these two modalities of treatment in persistent AF patients. The investigators therefore wish to prospectively investigate the safety and efficacy of this thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning will also be used to visualise the effects of ablation by analysis of scar formation.
The study hypothesises that thoracoscopics surgical ablation is a
Detailed description
This will be a pilot, prospective, observational study of catheter ablation compared with thoracoscopically assisted, surgical ablation strategies using a case control design.
The study population will be patients between the ages of 18 and 80 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.
Thoracoscopically Assisted Surgical Ablation Group Patients assigned to this group will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation Group Patients will undergo pulmonary vein isolation, linear and electrogram based ablation.
Recurrences Only one redo procedure is allowed for atrial tachyarrhythmia recurrences in the 12 month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopically Assisted Surgical Ablation | Experimental | Procedure: Thoracoscopically Assisted Surgical AblationThis arm will have an index thoracoscopically assisted surgical ablation. |
| Catheter Ablation | Active comparator | Procedure: Catheter AblationThis is an active comparator arm where study subjects will undergo conventional catheter ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤ 80
- Symptomatic persistent AF (≥1≤5 years), refractory to at least 1 AAD and/or DCCV
- Patient is legally competent and willing and able to sign informed consent form
- Patient is willing and able to adhere to follow up visit protocols for the duration of the study
Key exclusion criteria (10 listed)
- Left ventricular ejection fraction < 40%
- Cardiovascular implantable electronic device (contraindicates MRI imaging)
- Contraindication to anticoagulation
- Thrombus in the LA despite anticoagulation
- CVA within the previous 6 months
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 |
|---|---|---|
| Thoracoscopically Assisted Surgical AblationSurgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion. | Procedure or surgery | Thoracoscopically Assisted Surgical Ablation |
| Catheter AblationIn this arm, study subjects will undergo conventional catheter ablation as their index procedure. This will include pulmonary vein isolation, linear and electrogram based ablation. | Procedure or surgery | Catheter Ablation |
Primary outcome
Freedom from atrial tachyarrhythmias at 12 months.
Time frame: 12 months
Freedom from atrial tachyarrhythmias at 12 months which will be analysed with or without anti-arrhythmic drugs (AAD). Monitoring will be undertaken with ambulatory ECG monitoring in compliance with latest international guidelines.
5 secondary outcomes
Freedom from atrial tachyarrhythmias at 12 months from a single procedure on/off AAD;
Time frame: 12 months
Change in AF symptom score
Time frame: Various time points 0,3,6,9,12 months
Integrity of ablation lesion after index procedure at 3 months (as assessed by MRI if in SR +/- electrophysiologically if redo procedure is undertaken for atrial arrhythmia recurrence);
Time frame: 3 months
Freedom of serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up.
Time frame: 12 months
Cost analysis (procedural and hospital stay costs).
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 30 Jun 2011.
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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, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopically Assisted Surgical Ablation and Catheter Ablation in people with Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site 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 4 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 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 tachyarrhythmias at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2011.