DECAAF II
Trial question
Is MRI-guided fibrosis ablation superior to conventional catheter ablation in patients with persistent AF?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 843
843 patients (178 female, 665 male).
Inclusion criteria: patients with persistent AF.
Key exclusion criteria: previous LA ablation or valvular cardiac surgery; contraindication to gadolinium and/or MRI; contraindication to β-blockers.
Interventions
N=421 MRI-guided fibrosis ablation (pulmonary vein isolation followed by ablation of all fibrotic areas observed on MRI).
N=422 pulmonary vein isolation alone (electrical isolation of all pulmonary veins).
Primary outcome
Atrial arrhythmia recurrence
43%
46.1%
46.1 %
34.6 %
23.1 %
11.5 %
0.0 %
MRI-guided fibrosis
ablation
Pulmonary vein isolation
alone
No significant
difference ↔
No significant difference in atrial arrhythmia recurrence (43% vs. 46.1%; HR 0.95, 95% CI 0.77 to 1.17).
Secondary outcomes
No significant difference in atrial arrhythmia recurrence, repeat ablation or new atrial arrhythmia medication (45% vs. 48%; HR 0.95, 95% CI 0.78 to 1.16).
No significant difference in repeat ablation (14% vs. 17.6%; HR 0.8, 95% CI 0.56 to 1.12).
No significant difference in atrial arrhythmia recurrence, repeat ablation, new atrial arrhythmia medication or cardioversion (45.9% vs. 48.5%; HR 0.96, 96% CI 0.79 to 1.17).
Safety outcomes
Significant differences in ≥ 1 event of death, stroke, pulmonary vein stenosis, HF, or bleeding within 30 days postablation (2.2% vs. 0%).
Conclusion
In patients with persistent AF, MRI-guided fibrosis ablation was not superior to pulmonary vein isolation alone with respect to atrial arrhythmia recurrence.
Reference
Nassir F Marrouche, Oussama Wazni, Christopher McGann et al. Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The DECAAF II Randomized Clinical Trial. JAMA. 2022 Jun 21;327(23):2296-2305.
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