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Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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 °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

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Data are available for review.

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Funding

This work was supported by Advanced Cardiac Therapeutics, Santa Clara, California, USA. Dr. Neuzil have received research grant support from Advanced Cardiac Therapeutics, Inc. Dr. Reddy has served as a consultant to and has received research grant support from Advanced Cardiac Therapeutics, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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Authors and Affiliations

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

    Zdenek Starek, Frantisek Lehar, Jiri Jez & Martin Pesl

  2. First Department of Internal Medicine/Cardioangiology, St. Anne’s Hospital, Masaryk University, Pekařská 53, 656 91, Brno, Czech Republic

    Zdenek Starek, Frantisek Lehar, Jiri Jez & Martin Pesl

  3. Department of Biology, Faculty of Medicine, Masaryk University, Kamenice 753/5, 625 00, Brno, Czech Republic

    Martin Pesl

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

    Petr Neuzil, Lucie Sediva, Jan Petru, Libor Dujka & Moritoshi Funasako

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

    Josef Kautzner, Petr Peichl & Bashar Aldhoon

  6. Department of Medicine I, Palacky University Hospital, Olomouc, Czech Republic

    Josef Kautzner

  7. Cardiology – Heart Rhythm Management Department, Clinique Pasteur, 45 Avenue de Lombez, 31076, Toulouse, France

    Jean-Paul Albenque, Stephane Combes & Serge Boveda

  8. Universiteit Ziekenhuis, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090, Jette, Brussels, Belgium

    Serge Boveda

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

    Srinivas R. Dukkipati & Vivek Y. Reddy

Authors
  1. Zdenek Starek
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  2. Frantisek Lehar
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  3. Jiri Jez
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  4. Martin Pesl
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  5. Petr Neuzil
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  6. Lucie Sediva
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  7. Jan Petru
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  9. Moritoshi Funasako
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  10. Josef Kautzner
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  11. Petr Peichl
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  13. Jean-Paul Albenque
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  14. Stephane Combes
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  15. Serge Boveda
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  16. Srinivas R. Dukkipati
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  17. Vivek Y. Reddy
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Corresponding author

Correspondence to Zdenek Starek.

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The study was approved by the institutional review boards at each of the 4 clinical sites.

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Starek, Z., Lehar, F., Jez, J. et al. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. J Interv Card Electrophysiol 64, 375–381 (2022). https://doi.org/10.1007/s10840-021-00986-0

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