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Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.

Publication ,  Journal Article
Pokorney, SD; Friedman, DJ; Calkins, H; Callans, DJ; Daoud, EG; Della-Bella, P; Jackson, KP; Shivkumar, K; Saba, S; Sapp, J; Stevenson, WG ...
Published in: Heart Rhythm
August 2016

Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials of VT catheter ablation had to be stopped prematurely. The main challenges are inability to blind the patient to therapy to obtain a traditional control group, high crossover rates between the 2 arms of the study, patient refusal to participate in trials in which they have an equal chance of receiving a "pill" vs an invasive procedure, heterogeneity of mapping and ablation techniques as well as catheters and equipment, rapid evolution of technology that may make findings of any long trial less relevant to clinical practice, lack of consensus on what constitutes acute procedural and long-term success, and presentation of patients to electrophysiologists late in the course of their disease. In this article, a panel of experts on VT catheter ablation and/or clinical trials of VT catheter ablation review challenges faced in conducting prior trials of VT catheter ablation and offer potential solutions for those challenges. It is hoped that the proposed solutions will enhance the feasibility of randomized clinical trials of VT catheter ablation.

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Published In

Heart Rhythm

DOI

EISSN

1556-3871

Publication Date

August 2016

Volume

13

Issue

8

Start / End Page

1748 / 1754

Location

United States

Related Subject Headings

  • Tachycardia, Ventricular
  • Recurrence
  • Humans
  • Clinical Trials as Topic
  • Catheter Ablation
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1102 Cardiorespiratory Medicine and Haematology
  • 0903 Biomedical Engineering
 

Citation

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Pokorney, S. D., Friedman, D. J., Calkins, H., Callans, D. J., Daoud, E. G., Della-Bella, P., … Al-Khatib, S. M. (2016). Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials. Heart Rhythm, 13(8), 1748–1754. https://doi.org/10.1016/j.hrthm.2016.04.001
Pokorney, Sean D., Daniel J. Friedman, Hugh Calkins, David J. Callans, Emile G. Daoud, Paolo Della-Bella, Kevin P. Jackson, et al. “Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.Heart Rhythm 13, no. 8 (August 2016): 1748–54. https://doi.org/10.1016/j.hrthm.2016.04.001.
Pokorney SD, Friedman DJ, Calkins H, Callans DJ, Daoud EG, Della-Bella P, et al. Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials. Heart Rhythm. 2016 Aug;13(8):1748–54.
Pokorney, Sean D., et al. “Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.Heart Rhythm, vol. 13, no. 8, Aug. 2016, pp. 1748–54. Pubmed, doi:10.1016/j.hrthm.2016.04.001.
Pokorney SD, Friedman DJ, Calkins H, Callans DJ, Daoud EG, Della-Bella P, Jackson KP, Shivkumar K, Saba S, Sapp J, Stevenson WG, Al-Khatib SM. Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials. Heart Rhythm. 2016 Aug;13(8):1748–1754.
Journal cover image

Published In

Heart Rhythm

DOI

EISSN

1556-3871

Publication Date

August 2016

Volume

13

Issue

8

Start / End Page

1748 / 1754

Location

United States

Related Subject Headings

  • Tachycardia, Ventricular
  • Recurrence
  • Humans
  • Clinical Trials as Topic
  • Catheter Ablation
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1102 Cardiorespiratory Medicine and Haematology
  • 0903 Biomedical Engineering