About the DIAMOND-AF Trial
The DIAMOND-AF trial is a prospective, multicenter, single blind, non-inferiority, randomized, controlled trial designed to compare the safety and effectiveness of the DTA system against a contact force-sensing ablation system (control arm) for the treatment of patients with recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) whose condition is unresponsive to drug therapy. The trial enrolled 482 patients (239 DTA, 243 control) across 23 sites in the United States, Europe and Canada. DIAMOND-AF is the largest completed AF ablation technology IDE trial which resulted in FDA approval to date.
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Results demonstrated a freedom from patient complication rate of 96.7% in the DTA group versus 93.4% in the control (P<0.0001 versus -6.5% non-inferiority margin). Primary effectiveness for the treatment of AF was met in 79.1% of DTA and 75.7% of control subjects (P<0.0001 versus -12.5% non-inferiority margin).
Additionally, the DTA system demonstrated procedural advantages compared to the control group, with shorter total RF times and individual RF ablation duration, and reduction in volume of infused saline. A clinically meaningful quality-of-life improvement was also observed in both arms at 6 and 12-months post-ablation. These findings were presented as a late-breaking clinical trial at the 2020 Asia Pacific Heart Rhythm Society (APHRS) Virtual Congress in October and were published in the Journals of the American College of Cardiology Clinical Electrophysiology (JACC EP) in January 2021.
"The DIAMOND-AF trial results are encouraging not only because the DTA system was shown to be safe and effective, but because the outcomes underscored significant procedural efficiencies for clinicians," said JACC EP corresponding author Tom McElderry, M.D., University of Alabama, Birmingham. "Improved efficiencies – including shorter total RF ablation times and individual RF ablation durations, are important for both the well-being of the patient and the productivity of the physician and lab staff."
The full manuscript of the DIAMOND-AF trial can be found here.
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