Catheter versus thoracoscopic surgical ablation in long standing persistent atrial fibrillatio

Not Applicable

Completed

• Conditions: Arrhythmia; Circulatory System; Cardiac arrhythmia, unspecified

• Registration Number: ISRCTN18250790
• Lead Sponsor: Royal Brompton & Harefield NHS trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29458408 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32860414/ results (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34726873/ (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-24
• Study Completion: 2019-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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