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Design and Rationale of the Assessment of Proper Physiologic Response with Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer (APPROPRIATE) Trial

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Abstract

Rate-adaptive sensors are designed to restore a physiologic heart rate response to activity, in particular for patients that have chronotropic incompetence (CI). Limited data exist comparing two primary types of sensors; an accelerometer (XL) sensor which detects activity or motion and a minute ventilation (MV) sensor, which detects the product of respiration rate and tidal volume. The APPROPRIATE study will evaluate the MV sensor compared with the XL sensor for superiority in improving functional capacity (peak VO2) in pacemaker patients that have CI. This study is a double-blind, randomized, two-arm trial that will enroll approximately 1,000 pacemaker patients. Patients will complete a 6-min walk test at the 2-week visit to screen for potential CI. Those projected to have CI will advance to a 1-month visit. At the 1-month visit, final determination of CI will be done by completing a peak exercise treadmill test while the pacemaker is programmed to DDDR with the device sensors set to passive. Patients failing to meet the study criteria for CI will not continue further in the trial. Patients that demonstrate CI will be randomized to program their rate-adaptive sensors to either MV or XL in a 1:1 ratio. The rate-adaptive sensor will be optimized for each patient using a short walk to determine the appropriate response factor. At a 2-month visit, patients will complete a CPX test with the rate-adaptive sensors in their randomized setting.

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Author information

Authors and Affiliations

  1. Cardiology Associates of NE Arkansas, One Medical Plaza, 201 East Oak, Suite 101, Jonesboro, AR, 72401, USA

    F. Roosevelt Gilliam III

  2. Genesis Heart Institute, Davenport, IA, USA

    Michael Giudici

  3. Cardiovascular Consultants Medical Group, Walnut Creek, CA, USA

    Andrew Benn

  4. Brigham and Women’s Hospital, Boston, MA, USA

    Bruce Koplan

  5. Boston Scientific, St. Paul, MN, USA

    Kellie Jean Chase Berg, Kira Q. Stolen, Guy E. Alvarez & Donald L. Hopper

  6. The Integra Group, Brooklyn Park, MN, USA

    Stacia Merkel Kraus

  7. Cleveland Clinic, Cleveland, OH, USA

    Bruce L. Wilkoff

Authors
  1. F. Roosevelt Gilliam III
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  2. Michael Giudici
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  3. Andrew Benn
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  4. Bruce Koplan
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  5. Kellie Jean Chase Berg
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  6. Stacia Merkel Kraus
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  7. Kira Q. Stolen
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  8. Guy E. Alvarez
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  9. Donald L. Hopper
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  10. Bruce L. Wilkoff
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Corresponding author

Correspondence to F. Roosevelt Gilliam III.

Additional information

This trial is funded by Boston Scientific.

This trial has been registered on www.ClinicalTrials.gov with identifier NCT00757666.

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Gilliam, F.R., Giudici, M., Benn, A. et al. Design and Rationale of the Assessment of Proper Physiologic Response with Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer (APPROPRIATE) Trial. J. of Cardiovasc. Trans. Res. 4, 21–26 (2011). https://doi.org/10.1007/s12265-010-9228-0

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  • DOI: https://doi.org/10.1007/s12265-010-9228-0

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