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N/A N=578

Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

Bradyarrhythmia

Enrolled (actual)
578
Serious AEs
Results posted
Dec 2017
Primary outcome: Primary: Acceptance of TherapyGuide Proposals and Typology of Programming Changes — 46 percentage of patients

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
TherapyGuide (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Acceptance of TherapyGuide Proposals and Typology of Programming Changes
46

Summary

The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming. TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles. Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known. The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.

Eligibility Criteria

Inclusion Criteria

  • Patient implanted with a pacemaker featuring the TherapyGuide function
  • Patient more than 18 years of age.
  • Patient able to sign a data release authorization form

Exclusion Criteria

  • Unwillingness or inability to provide written consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01513538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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