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Treatment of atrial fibrillation in patients with enhanced sympathetic tone by pulmonary vein isolation or pulmonary vein isolation and renal artery denervation: clinical background and study design

The ASAF trial: ablation of sympathetic atrial fibrillation

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Abstract

Background

Hypertension is an important, modifiable risk factor for the development of atrial fibrillation (AF). Even after pulmonary vein isolation (PVI), 20–40% experience recurrent AF. Animal studies have shown that renal denervation (RDN) reduces AF inducibility. One clinical study with important limitations suggested that RDN additional to PVI could reduce recurrent AF.

Objective

The goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence.

Methods

The main end point is the time until first AF recurrence according to EHRA guidelines after a blanking period of 3 months. Assuming a 12-month accrual period and 12 months of follow-up, a power of 0.80, a two-sided alpha of 0.05 and an expected drop-out of 10% per group, 69 patients per group are required. We plan to randomize a total of 138 hypertensive patients with AF and signs of sympathetic overdrive in a 1:1 fashion. Patients should use at least two antihypertensive drugs. Sympathetic overdrive includes obesity, exercise-induced excessive blood pressure (BP) increase, significant white coat hypertension, hospital admission or fever induced AF, tachycardia induced AF and diabetes mellitus. The interventional group will undergo PVI + RDN and the control group will undergo PVI.

Results

Patients will have follow-up for 1 year, and continuous loop monitoring is advocated.

Conclusion

This randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.

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Authors and Affiliations

  1. Department of Cardiology, Isala Hospital, Zwolle, The Netherlands

    Mark R. de Jong, Annemiek F. Hoogerwaard, Ahmet Adiyaman, Jaap Jan J. Smit, Anand R. Ramdat Misier & Arif Elvan

  2. Department of Internal Medicine, Isala Hospital, Zwolle, The Netherlands

    Jan-Evert Heeg

  3. Department of Radiology, Isala Hospital, Zwolle, The Netherlands

    Boudewijn A. A. M. van Hasselt

  4. Department of Cardiology, University of Groningen, Groningen, The Netherlands

    Isabelle C. Van Gelder

  5. Department of Cardiology, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands

    Harry J. G. M. Crijns

  6. Department of Arrhythmia Unit, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain

    Ignacio Fernández Lozano & Jorge E. Toquero Ramos

  7. Department of Arrhythmia Unit, Hospital Universitario Virgen de la Victoria, Málaga, Spain

    F. Javier Alzueta

  8. Department of Cardiology, Hospital Fundación Jimenez Díaz, Madrid, Spain

    Borja Ibañez & José M. Rubio

  9. Department of Cardiology, Hospital Universitario 12 de Octubre, Madrid, Spain

    Fernando Arribas

  10. Department of Cardiology, Hospital Donostia, San Sebastian, Spain

    José M. Porres Aracama

  11. Arrhythmia Unit, Cardiovascular Institute, Hospital Clínic, University of Barcelona, Barcelona, Spain

    Josep Brugada & Lluís Mont

Authors
  1. Mark R. de Jong
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  2. Annemiek F. Hoogerwaard
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  18. Lluís Mont
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  19. Arif Elvan
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Corresponding author

Correspondence to Arif Elvan.

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Conflict of interest

The study receives sponsoring from the Medtronic External Research Program. Dr. J. Toquero Ramos reports his membership of the Medtronic European Advisory Board. The other authors declare no conflict of interest.

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de Jong, M.R., Hoogerwaard, A.F., Adiyaman, A. et al. Treatment of atrial fibrillation in patients with enhanced sympathetic tone by pulmonary vein isolation or pulmonary vein isolation and renal artery denervation: clinical background and study design. Clin Res Cardiol 107, 539–547 (2018). https://doi.org/10.1007/s00392-018-1214-6

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  • DOI: https://doi.org/10.1007/s00392-018-1214-6

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