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Cardiac ablation and mapping
A comparison of the DiamondTemp™ ablation system versus a contact force-sensing ablation system (CF-RF) in the DIAMOND-AF (DAF) clinical trial.
Tissue temperature is a well-established biophysical parameter of irreversible tissue damage. Irrigated RF was introduced to mitigate the risk of char and thrombus formation; however, thermal acuity is disrupted.
To address these limitations, the DiamondTemp™ ablation system (DTA) was designed to accurately measure tip-tissue temperature during energy delivery.
The DAF trial was an FDA-regulated, prospective, multicenter, non-inferiority, randomized, controlled trial which compared safety and effectiveness of DTA and a contact force-sensing ablation system (TactiCath™) (control).
482 paroxysmal atrial fibrillation (AF) patients were randomized (239 DTA and 243 control) for PVI at 23 sites in the United States, Europe, and Canada. Patients were followed for 12 months.
DTA demonstrated comparable efficacy and both cohorts required very few repeat procedures. Safety and efficacy of the DTA system proved non-inferior to contact force-sensing RF ablation for the treatment of patients with paroxysmal AF.
3.3% safety event rate compared with 6.6% with contact force-sensing RF.
79.1% compared with 75.7% with contact force-sensing RF.
The DTA system demonstrated procedural efficiencies compared to CF-RF in post-hoc analysis.1,2
Metric | DTA group2 |
Control group2 | % reduction |
---|---|---|---|
Total RF time | 17.9 ± 8.1 min | 29.8 ± 14 min | 39.9% |
Individual RF ablation duration | 14.7 ± 5.3 s | 32.6 ± 25.3 s | 54.9% |
Saline infusion volume | 332.2 ± 120.8 ml | 785.2 ± 351.5 ml | 57.7% |
The primary effectiveness endpoint was freedom from recurrence of an atrial arrhythmia (AF, AFL, AT) during the effectiveness period. This was a composite endpoint of seven (7) failure criteria.
The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30 days and clinically symptomatic pulmonary vein stenosis through 6 months post-index ablation procedure.
Freedom from recurrence of atrial arrhythmias (AF/AFL/AT)
Effectiveness Failure Criteria
Effectiveness Failure Criteria
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Medtronic data on file.
Kautzner J, Albenque JP, Natale A, et al. A novel temperature-controlled radiofrequency catheter ablation system used to treat patients with paroxysmal atrial fibrillation. JACC Clin Electrophysiol. 2021;7(3):352–363.