BACKGROUND AND PURPOSE: Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. METHODS: The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 °C, max 50 W). Acute and chronic efficacy and safety was evaluated. RESULTS: Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 ± 6.1 min and 20.6 ± 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). CONCLUSION: This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA. TRIAL REGISTRATION: Registered on the site ClinicalTrials.gov January 2016 with identifier: NCT02821351.

1st Department of Internal Medicine Cardioangiology St Anne's Hospital Masaryk University Pekařská 53 656 91 Brno Czech Republic

Cardiology Heart Rhythm Management Department Clinique Pasteur 45 Avenue de Lombez 31076 Toulouse France

Department of Biology Faculty of Medicine Masaryk University Kamenice 753 5 625 00 Brno Czech Republic

Department of Cardiology Institute for Clinical and Experimental Medicine Vídeňská 1958 9 140 21 Prague 4 Czech Republic

Department of Cardiology Na Homolce Hospital Roentgenova 2 15030 Prague Czech Republic

Department of Medicine 1 Palacky University Hospital Olomouc Czech Republic

Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai One Gustave L Levy Place Box 1030 New York NY 10029 USA

International Clinical Research Center Interventional cardiac electrophysiology group St Anne's University Hospital Brno Pekařská 53 656 91 Brno Czech Republic

Universiteit Ziekenhuis Vrije Universiteit Brussel Laarbeeklaan 101 1090 Jette Brussels Belgium

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NCT02821351