Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) (CASA-AF)
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|ClinicalTrials.gov Identifier: NCT02755688|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Procedure: Thoracoscopic Surgical ablation Procedure: Catheter ablation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Catheter Ablation Versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Thoracoscopic surgical ablation
Pulmonary vein isolation, ganglionic plexi ablation, left atrial appendage exclusion
Procedure: Thoracoscopic Surgical ablation
Thoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion
Active Comparator: Catheter ablation
Pulmonary vein isolation, linear lines
Procedure: Catheter ablation
Ablation using contact force technology to isolate pulmonary veins and create linear lesions.
- 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.
- 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 ]Measured by internal loop recorder and analysed by blinded core lab.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755688
|Contact: Habib Khan, MBBS||02073528121 ext firstname.lastname@example.org|
|Contact: Matthew Gill||02073528121 ext 2379||M.Gill@rbht.nhs.uk|
|Brighton and Sussex University Hospitals NHS Trust||Recruiting|
|Brighton, United Kingdom, BN2 5BE|
|Contact: James McCready, MBBS James.McCready@bsuh.nhs.uk|
|Liverpool Heart and Chest Hospital||Recruiting|
|Liverpool, United Kingdom|
|Contact: Dhiraj Gupta Gupta Dhiraj <Dhiraj.Gupta@lhch.nhs.uk>|
|Principal Investigator: Dhiraj Gupta|
|Royal Brompton and Harefield Hospital NHS Trusts||Recruiting|
|London, United Kingdom, SW36NP|
|Contact: Habib Khan, MBBS 02073528121 ext 2379 email@example.com|
|Principal Investigator:||Tom Wong||Royal Brompton & Harefield NHS Foundation Trust|