Arrhythmias & electrophysiology
Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial
Primary result · Absolute mean AF burden change from baselineResult — go to the resultGeometric mean difference 0.25 95% CI 0.15–0.42Authors' conclusion
Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.
Study context
- Population
- Patients with symptomatic paroxysmal or persistent AF, UK, January 2020 to March 2024
- Participants
- 126 patients
- Comparison
- PVI with cryoablation vs sham procedure
- Ablationn = 64
- Shamn = 62reference
- Primary endpoint
- AF burden (implantable loop recorder), excluding a 3-month blanking period
- Follow-up
- 6 months
Methodological detailsdouble-blind, sham-controlled, 2 tertiary centres in the UK
- Double-blind
- Sham-controlled
- 2 tertiary centres in the UK
Primary result
Absolute mean AF burden change from baseline
Geometric mean difference
0.25
95% CI 0.15–0.42
P < 0.001
Change by group
Ablation
60.31%
mean
Sham
35.0%
mean
Ablation vs Sham
geometric mean difference 0.25 (95% CI 0.15–0.42); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Estimated difference (points) (95% CI) | |
|---|---|---|
| Atrial Fibrillation Effect on Quality of Life score · 6 monthsFavoring catheter ablation | 18.39 (11.48–25.30) | |
| SF-36 general health score · 6 months | 9.27 (3.78–14.76) | |
| −2002040Difference, points (linear scale) |
Original publication
Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. Published 2 September 2024. doi:10.
Summarised from the published abstract; every number is checked against it