Arrhythmias & electrophysiology
Feasibility of double-blinded, placebo-controlled interventional study for assessing catheter ablation efficacy in persistent atrial fibrillation: Insights from the ORBITA AF feasibility study
Authors' conclusion
This feasibility study establishes the potential for conducting a blinded, placebo-controlled trial to evaluate the efficacy of PVI versus DCCV in patients with PersAF.
Study context
- Population
- Patients with persistent AF (duration <2 years), Barts Heart Centre, UKrandomised 1:1
- Participants
- 20 patients
- Comparison
- PVI ± DC cardioversion (DCCV) vs DCCV + placebo
- Primary endpoint
- Patient blinding
Methodological detailsdouble-blind, placebo-controlled, feasibility pilot, single-centre
- Double-blind
- Placebo-controlled
- Feasibility pilot
- Single-centre
Primary result
As reported in the abstract
Blinding
- Blinding successfully maintained amongst both patients and medical staff
Further findings
Recurrence of persistent AF · 12 months · trend
P = 0.07
Repeat procedure
P = 0.4
- Recurrence of persistent AF: overall 35% recurrence before 12-month follow-up completion
Quality of life in patients who maintained sinus rhythm at 12 months (AF PROMS; SF-12 mental-component raw score)
- Improved QoL in PVI group: AF PROMS 3 [±4] vs 21 [±8]
- SF-12 mental-component raw score 51.4 [±7] vs 43.24 [±15]
Original publication
Feasibility of double-blinded, placebo-controlled interventional study for assessing catheter ablation efficacy in persistent atrial fibrillation: Insights from the ORBITA AF feasibility study. Am Heart J. Published 17 December 2023. doi:10.
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