Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Catheter ablation, Ablation lesion, Pulmonary vein isolation, Pulsed field ablation, Cryoballoon ablation, Cardiac magnetic resonance, Late gadolinium enhancement
Brief summary
This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).
Detailed description
Pulmonary vein isolation (PVI) using catheter ablation has become a cornerstone in the treatment of AF and is considered the most effective therapy today. Catheter ablation has been mostly performed employing thermal energies, with radiofrequency and cryo-balloon ablation being the best validated most widely applied modalities. Despite substantial technological and procedural advances that have improved efficacy, efficiency and safety of AF ablation in recent years, long-term durability of ablation lesions is still not satisfactory, and rare but potentially life-threatening procedure-related complications like cardiac tamponade or atrio-esophageal fistula remain a concern. In addition, phrenic nerve palsy complicates a relevant proportion of procedures, particularly in cryo-ablation. The novel non-thermal ablation method of pulsed field ablation holds great promise in that respect. Pulsed field ablation achieves permanent cell death through electroporation, which appears to provide a unique selectivity for cardiomyocytes and to spare surrounding tissues composed of other cell types, thus minimising the risk of collateral damage.This method has already been introduced into routine clinical practice and is established in many centers worldwide. A large number of studies have confirmed safety and efficacy of pulsed field ablation for pulmonary vein isolation in the context of AF and found significant reductions in ablation times. However, the putative benefits regarding efficacy, efficiency and safety remain to be proven in randomised controlled trials. Against this background, the investigators aim to perform a randomised clinical trial comparing pulsed field ablation with thermal cryo-balloon ablation with respect to efficacy, effectiveness and safety. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System). The primary outcome of this trial will be ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation.
Interventions
PROCEDUREPulmonary vein isolation
Catheter ablation
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for first-time atrial fibrillation catheter ablation
Exclusion criteria
* age \<18 years * long-standing persistent atrial fibrillation * prior left atrial ablation * pregnancy or lactation * reduced left ventricular ejection fraction * GFR \<30% * BMI \>35% * left atrial diameter \>55 mm * cardiac implantable electronic device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LGE-CMR-determined ablation lesion quality | 3 months post-ablation | Complete late gadolinium enhancement encircling both pulmonarz vein pairs, with discontinuations adding up to less than 10% of the total length of the circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF-free survival | 3, 6 and 12 months post-ablation | — |
| Arrhythmia-free survival | 3, 6 and 12 months post-ablation | Freedom from atrial tachycardia, atrial flutter and AF |
| Time to first AF recurrence | 12, 24 and 36 months | — |
| Progression from paroxysmal to persistent AF | 12, 24 and 36 months | — |
| Time to first arrhythmia | 12, 24 and 36 months | — |
| Spatial LGE distribution according to local wall thickness (as assessed by preablation CT) | 3 months post-ablation | — |
| Complete pulmonary vein isolation confirmed by persistent entrance- and exit-block | intra-procedural | (per-pulmonary vein pair analysis and per-patient analysis |
| Safety events | periprocedural and 12 months | Vascular access complications, pericardial effusion / tamponade, phrenic nerve paly (temporal or permanent), atrio-esophageal fistula, esophageal ulcer, pulmonary vein stenosis, systemic embolism, stroke, TIA, death, cardiovascular death |
Countries
Spain
Outcome results
None listed