Catheter versus thoracoscopic surgical ablation in long standing persistent atrial fibrillation

Conditions

Arrhythmia Circulatory System Cardiac arrhythmia, unspecified

V Boyalla, Barbara Bodinier, Ines Kralj‐Hans, Shouvik Haldar, Habib Khan et al. (15 authors)

EP Europace2022-05-18

Thoracoscopic surgical ablation versus catheter ablation as first-line treatment for long-standing persistent atrial fibrillation: the CASA-AF RCT

Shouvik Haldar, Habib Khan, Vennela Boyalla, Ines Kralj‐Hans, Simon Jones et al. (29 authors)

Efficacy and Mechanism Evaluation2021-10-014 citations

10.3310/eme08180

Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial

Shouvik Haldar, Habib Khan, Vennela Boyalla, Ines Kralj‐Hans, Simon Jones et al. (29 authors)

European Heart Journal2020-08-0489 citations

10.1093/eurheartj/ehaa658

Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial

Habib Khan, Ines Kralj‐Hans, Shouvik Haldar, Toufan Bahrami, Jonathan R. Clague et al. (20 authors)

Trials2018-02-208 citations

10.1186/s13063-018-2487-9

Interventions

The study will compare outcomes in two groups of patients: one group will undergo catheter and the other surgical ablation of areas giving rise to atrial fibrillation. 1. Thoracoscopic Surgical AF Ab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. LSPAF (> 12 months’ duration) 3. EHRA > 2 4. Left ventricular ejection fraction = 40% 5. Suitable for either ablation procedure (added 05/05/2016)

Exclusion criteria

Exclusion criteria: Exclusion criteria as of 05/05/2016: 1. Valvular heart disease with severity greater than mild 2. Contraindication to anticoagulation 3. Thrombus in the left atrium despite anticoagulation in therapeutic range 4. Cerebrovascular accident within the previous 6 months 5. Previous thoracic or cardiac surgery (including surgical interventions for AF) 6. Prior left atrial catheter ablation for AF 7. Unable to provide informed written consent 8. Active malignancy, another severe concomitant condition or presence of implanted intracardiac devices that would preclude patient undergoing study specific procedures 9. Pregnant or breast-feeding, or women of childbearing age not using a reliable contraceptive method Previous exclusion criteria: 1. Significant valvular heart disease 2. Contraindication to anticoagulation 3. Thrombus in the left atrium despite anticoagulation 4. Cerebrovascular accident within the previous 6 months 5. Significant previous thoracic or cardiac surgery (including surgical interventions for AF) 6. Prior left atrial catheter ablation for AF 7. Unable to provide informed written consent 8. Active malignancy or another severe concomitant condition that would preclude patient undergoing study specific procedures 9. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method

Design outcomes

Primary

Measure	Time frame
The primary efficacy end-point is freedom from atrial arrhythmias after a single procedure without AADs at 12 months	—

Secondary

Measure	Time frame
Previous secondary outcome measures: 1. Intervention-related major complication rate defined as permanent injury or death, that requires intervention for treatment, or prolongs or requires hospitalization for more than 48 hours 2. Clinical success, defined as a 75% or greater reduction of AF burden assessed by implantable loop recorder at 12 months with or without AADs. 3. Freedom from atrial arrhythmia, after multiple procedures without AADs at 12 months 4. Atrial anatomy and function following ablation as assessed by echocardiography and CMR 5. Change in AF symptom score (EHRA score) and quality of life assessments (EQ5D, AFEQT) 6. Quality Adjusted Life Years (QALYs) accrued during the 12-month study period 7.Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated over the 12-month study period (‘within trial’ analysis) and over a lifetime horizon (estimated by modeling) Current secondary outcome measures as of 22/03/2017: 1. 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 2. Clinical success, defined as a 75% or greater reduction of AF burden assessed by implantable loop recorder at 12 months with or without AADs. 3. Freedom from atrial arrhythmia, after multiple procedures without AADs at 12 months 4. Atrial anatomy and function following ablation as assessed by echocardiography and CMR 5. Change in AF symptom score (EHRA score) and quality of life assessments (EQ5D, AFEQT) 6. Quality Adjusted Life Years (QALYs) accrued during the 12-month study period 7.Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated over the 12-month study period (‘within trial’ analysis) and over a lifetime horizon (estimated by modeling)	—

Measure

Time frame

Previous secondary outcome measures: 1. Intervention-related major complication rate defined as permanent injury or death, that requires intervention for treatment, or prolongs or requires hospitalization for more than 48 hours 2. Clinical success, defined as a 75% or greater reduction of AF burden assessed by implantable loop recorder at 12 months with or without AADs. 3. Freedom from atrial arrhythmia, after multiple procedures without AADs at 12 months 4. Atrial anatomy and function following ablation as assessed by echocardiography and CMR 5. Change in AF symptom score (EHRA score) and quality of life assessments (EQ5D, AFEQT) 6. Quality Adjusted Life Years (QALYs) accrued during the 12-month study period 7.Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated over the 12-month study period (‘within trial’ analysis) and over a lifetime horizon (estimated by modeling) Current secondary outcome measures as of 22/03/2017: 1. 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 2. Clinical success, defined as a 75% or greater reduction of AF burden assessed by implantable loop recorder at 12 months with or without AADs. 3. Freedom from atrial arrhythmia, after multiple procedures without AADs at 12 months 4. Atrial anatomy and function following ablation as assessed by echocardiography and CMR 5. Change in AF symptom score (EHRA score) and quality of life assessments (EQ5D, AFEQT) 6. Quality Adjusted Life Years (QALYs) accrued during the 12-month study period 7.Cost-effectiveness (Incremental Cost per QALY gained) for surgical ablation compared with CA estimated over the 12-month study period (‘within trial’ analysis) and over a lifetime horizon (estimated by modeling)

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Countries

England, United Kingdom

Outcome results

None listed