Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, catheter ablation, individualized mapping, focal activity, rotational activity
Brief summary
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)
Interventions
PROCEDUREPulmonary veins isolation + Cartofinder-guided ablation
The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.
PROCEDUREPulmonary veins isolation
Wide area circumferential pulmonary veins isolation
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years old 2. Signed informed consent. 3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation. 4. In atrial fibrillation at the time of the index procedure.
Exclusion criteria
1. Paroxysmal atrial fibrillation. 2. Previous ablation procedure for atrial fibrillation. 3. Left ventricular ejection fraction \< 45% 4. Obesity with BMI \> 35 kg/m2 5. Congenital heart disease. 6. Previous cardiac surgery with atriotomy. 7. Previous left atrial appendage closure/ligation. 8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia. 9. Pregnancy 10. Current enrolment in a study evaluating another device or drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial arrhythmia | 12 monts | Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial fibrillation | 12 months | Freedom from atrial fibrillation without the use of antiarrhythmic drugs |
| Atrial fibrillation burden reduction | 12 months | Reduction of the atrial fibrillation burden by 75% compared to baseline |
| Absolute atrial fibrillation burden | 12 months | Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach. |
Contacts
Primary ContactVias Markides, MD, FESC
Outcome results
None listed