EP Trials Highlights 2025
heartRhythmBox
heartRhythmBox
| Endpoint | Ablation (N=203) | Drugs (N=213) | HR (95% CI) |
|---|---|---|---|
| Primary Endpoint | 103 (50.7%) | 129 (60.6%) | 0.75 (0.58-0.97) |
| Death from any cause | 45 (22.2%) | 54 (25.4%) | 0.84 (0.56-1.24) |
| Appropriate ICD Shock | 60 (29.6%) | 81 (38.0%) | 0.75 (0.53-1.04) |
| VT Storm | 44 (21.7%) | 50 (23.5%) | 0.95 (0.63-1.42) |
| Treated VT below ICD Detection Zone | 9 (4.4%) | 35 (16.4%) | 0.26 (0.13-0.55) |
| Adverse Event Category | Catheter Ablation (N=203) | Drugs (N=213) | Notes |
|---|---|---|---|
| Serious Adverse Event | 57 (28.1%) | 65 (30.5%) | |
| Fatal Events | 45 (22.2%) | 54 (25.4%) | 44% of all deaths were CV deaths; 4% from ventricular arrhythmia |
| Non-Fatal Serious Adverse Events | 57 (28.1%) | 65 (30.5%) | |
| Adverse Events within 30 days of an Ablation Procedure | 23 (11.3%) | 10* (x-over to ablation) |
Included death in 2 patients (1.0%), nonfatal stroke in 2 patients (1.0%), and cardiac perforation in 1 patient (0.5%) |
| Adverse Events Attributed to Antiarrhythmic Drug | 7 (3.4%) | 46 (21.6%) | Included death due to pulmonary toxicity in 1 patient (0.5%) and 7 patients (3.3%) with pulmonary fibrosis. |
| Time Interval | Pulsed Field Ablation (N=105) |
Cryoballoon Ablation (N=105) |
Difference (95% CI) |
|---|---|---|---|
| Days 1 to 90 | |||
| Median percentage (IQR) | 0.0 (0.0 to 0.2) | 0.2 (0.0 to 1.2) | — |
| Mean percentage | 3.2±0.8 | 5.5±1.0 | −2.4 (−4.5 to −0.3) |
| Days 91 to 365 | |||
| Median percentage (IQR) | 0.0 (0.0 to 0.1) | 0.0 (0.0 to 0.2) | — |
| Mean percentage | 1.4±0.4 | 1.9±0.4 | −0.5 (−1.4 to 0.4) |
| Days 1 to 365 | |||
| Median percentage (IQR) | 0.0 (0.0 to 0.2) | 0.06 (0.0 to 0.7) | — |
| Mean percentage | 1.6±0.4 | 2.5±0.4 | −0.9 (−1.8 to 0.1) |
| End Point | Pulsed Field Ablation (N=105) |
Cryoballoon Ablation (N=105) |
Risk Ratio (95% CI) |
|---|---|---|---|
| Hospitalization or ER visit for atrial arrhythmia | 2 (1.9) | 8 (7.6) | 0.25 (0.05 to 1.15) |
| Repeat ablation procedure | 16 (15.2) | 10 (9.5) | 1.60 (0.76 to 3.37) |
| Reinitiation of antiarrhythmic drug | 3 (2.9) | 3 (2.9) | 1.00 (0.21 to 4.86) |
| Stroke or TIA> | |||
| -Periprocedural | 1 (1.0) | 2 (1.9) | 0.50 (0.05 to 5.46) |
| -Late | 0 | 2; 7 mos and 10 mos | |
| Death | 1 (1.0)* From cancer at 11mos |
0 | NA |
