STÁREK, Zdeněk, František LEHAR, Jiří JEŽ, Martin PEŠL, Petr NEUZIL, Lucie SEDIVA, Jan PETRU, Libor DUJKA, Moritoshi FUNASAKO, Josef KAUTZNER, Petr PEICHL, Bashar ALDHOON, Jean-Paul ALBENQUE, Stephane COMBES, Serge BOVEDA, Srinivas R. DUKKIPATI and Vivek Y. REDDY. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. Journal of interventional cardiac electrophysiology. Dordrecht: Springer, 2022, vol. 64, No 2, p. 375-381. ISSN 1383-875X. Available from: https://dx.doi.org/10.1007/s10840-021-00986-0.
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Basic information
Original name Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study
Authors STÁREK, Zdeněk (203 Czech Republic, guarantor, belonging to the institution), František LEHAR (203 Czech Republic, belonging to the institution), Jiří JEŽ (203 Czech Republic, belonging to the institution), Martin PEŠL (203 Czech Republic, belonging to the institution), Petr NEUZIL (203 Czech Republic), Lucie SEDIVA (203 Czech Republic), Jan PETRU (203 Czech Republic), Libor DUJKA (203 Czech Republic), Moritoshi FUNASAKO, Josef KAUTZNER (203 Czech Republic), Petr PEICHL (203 Czech Republic), Bashar ALDHOON, Jean-Paul ALBENQUE, Stephane COMBES, Serge BOVEDA, Srinivas R. DUKKIPATI and Vivek Y. REDDY.
Edition Journal of interventional cardiac electrophysiology, Dordrecht, Springer, 2022, 1383-875X.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30201 Cardiac and Cardiovascular systems
Country of publisher Netherlands
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 1.800
RIV identification code RIV/00216224:14110/22:00124969
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1007/s10840-021-00986-0
UT WoS 000658058700001
Keywords in English Catheter radiofrequency ablation; Atrial fibrillation; Diamond tip irrigated catheter; Temperature contol ablation; High-resolution electrograms; Safety and efficacy
Tags 14110115, 14110513, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 16/1/2023 12:17.
Abstract
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 degrees 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 inman 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.
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