Cardiovascular disease Circulatory System
Conditions
Interventions
This will be a multicentre study, in which it is anticipated that six sites will be involved. These sites will initially be selected from those with significant experience with the multielectrode radi
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Symptomatic paroxysmal or persistent atrial fibrillation 2. Suitable for clinically indicated catheter ablation 3. Aged > 18 years 4. Patients must be willing and able to provide informed consent 5. Patients must be willing and able to comply with peri-ablation and follow-up requirements
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planning pregnancy 2. Current enrollment in another interventional trial 3. Previous ablation for atrial fibrillation 4. Previous cardiac surgery 5. LA diameter > 55 mm in TTE 6. Patients with contraindications to systemic anticoagulation 7. Congenital heart disease 8. Body Mass Index > 40 9. Longstanding persistent atrial fibrillation (> 1 year) Intraprocedural criteria: Patients not tolerating insertion of the oesophageal temperature probe Postprocedural criteria: Patients not completing oesophageal endoscopy within 7 days of the ablation procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of acute Pulmonary Vein Isolation (PVI), defined as entrance block in all treated Pulmonary Veins measured using electronic case report form (eCRF) during the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be measured using electronic case report form (eCRF) recording during the procedure: 1. Rate of “first pass” PVI will be defined as the percentage of PVs where only one RF application is required to achieve entrance block 2. Time to PVI, expressed in seconds 3. Rate of significant oesophageal temperature rises (>2ºC from baseline) will be defined as the total number of oesophageal temperature rises within the entire sample size 4. Time for temperature to return to baseline (when a significant (>2°C) oesophageal temperature rise occurs) will be expressed in seconds 5. The rate of endoscopically detected oesophageal lesions (EDEL). These will be defined as a typical endoscopical finding of the oesophageal mucosa in an area neighbouring the LA and are classified as either category 1 lesion (mild: erythema/erosion or small ulcers =5mm diameter) or category 2 (severe) lesion (ulcer >5mm diameter). This will be expressed as a proportion and descriptive statistics will be provided. | — |
Countries
Belgium, England, Greece, United Kingdom
Contacts
Public ContactJohn Silberbauer
Outcome results
None listed