- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02755688
Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) (CASA-AF)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Brighton, United Kingdom, BN2 5BE
- Brighton and Sussex University Hospitals NHS Trust
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Liverpool, United Kingdom
- Liverpool Heart and Chest Hospital
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London, United Kingdom, SW36NP
- Royal Brompton and Harefield Hospital NHS Trusts
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥ 18 yrs.
- LSPAF (> 12 months' duration)
- EHRA>2
- Left ventricular ejection fraction ≥ 40%
- Suitable for either ablation procedure
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Thoracoscopic surgical ablation
Pulmonary vein isolation, ganglionic plexi ablation, left atrial appendage exclusion
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Thoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion
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ACTIVE_COMPARATOR: Catheter ablation
Pulmonary vein isolation, linear lines
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Ablation using contact force technology to isolate pulmonary veins and create linear lesions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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Clinical success from the arrhythmia interventions - defined as a 75% or greater reduction of AF burden with or without AADs.
Time Frame: 12 months
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12 months
|
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Freedom from atrial arrhythmia, after multiple procedures without AADs
Time Frame: 12 months
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Measured by internal loop recorder and analysed by blinded core lab.
|
12 months
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Changes in atrial anatomy and function following ablation as assessed by echocardiography using tissue Doppler and strain
Time Frame: 12 months
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12 months
|
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Changes in atrial anatomy and atrial fibrosis following ablation as assessed by cardiac MRI
Time Frame: 12 months
|
12 months
|
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Effects of the arrhythmia interventions on the patients' symptoms by Change in AF symptom score (EHRA score)
Time Frame: 12 months
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12 months
|
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Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (EQ5D)
Time Frame: 12 months
|
12 months
|
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Effects of the arrhythmia interventions on the quality of life as assessed by change in quality of life assessments (AFEQT)
Time Frame: 12 months
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12 months
|
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Quality Adjusted Life Years (QALYs) accrued during follow up
Time Frame: 12 months
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12 months
|
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Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014CI005B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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