Table 1.
CASTLE-AF | RAFT-AF | CASTLE-HTX | AMICA TRIAL | CAMERA- MRI |
|
---|---|---|---|---|---|
Year | 2018 | 2022 | 2023 | 2019 | 2017 |
Design | Multicenter open label RCT |
Multicenter open-label RCT |
Single-center open-label RCT |
Multicenter open-label RCT |
Multicenter RCT |
Mean age (years) | 64 ± 5 | 67 ± 8 | 64 ± 11 | 65 ± 8 | 61 ± 10 |
AF type | Parox: 32.5% Pers: 38.3% LS-pers: 29.2% |
Parox: 7.3% Pers: 69.3% LS-pers: 23.4% |
Parox: 30% Pers: 56% LS-pers: 14% |
Pers: 76.4% LS-pers: 23.6% |
Pers: 100% |
Baseline LVEF | 25–38% | 41 ± 15% | 27 ± 6% | 26 ± 9% | 33 ± 9% |
NYHA | I: 11% II: 60% III: 28% IV: 1% |
II: 67% III: 33% |
II: 31% III: 55% IV: 14% |
II: 39% III: 61% |
Mean NYHA class: 2.5 ± 0.6 |
Adjunctive ablation targets other than PVI | ND | 91.2% | ND | 33% | 100% |
Control arm therapy | Medical therapy | Rate control | Guideline directed |
Best medical therapy | Rate control |
Primary outcome | All-cause mortality and HF hospitalization | All-cause mortality and HF events | Death from any cause, LVAD implantation or urgent heart TX | Absolute increase in LVEF | Change in LVEF at 6 months |
Mean change in LVEF (ablation vs. control) | 8.0% vs. 0.2% | 10.1 ± 1.2 vs. 3.8 ± 1.2 | 7.8 ± 7.6 vs. 1.4 ± 7.2 | 8.8% vs. 7.3% | 18.3% vs. 4.4% |
Rhythm control outcome (ablation vs. control) | 63.1 vs. 21.7% in SR (5 years) | 85.6 vs. 12.9% in SR at 2 years | 31.4 ± 33.3 vs. 8.6 ± 26.3 AF burden reduction at 1 year | 73.5% vs. 50% in SR | 25% vs. 100% in AF |
Main findings | Reduction in all-cause death or HF hospitalization | Similar primary outcomes and increase in LVEF | Reduction in primary composite endpoint | No LVEF improvement | LVEF improvement |
Follow-up (months) | 38 | 37 | 18 | 12 | 6 |
RCT: randomized controlled trial; AF: atrial fibrillation; Parox: paroxysmal AF; Pers: persistent AF; LS-Pers: long-standing AF; LVEF: left ventricular ejection fraction; SR: sinus rhythm; HF: heart failure; LVAD: left ventricular assist device; heart TX: heart transplantation; PVI: pulmonary vein isolation; NYHA: New York Heart Association score.