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

NCT01513538 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-07-02

Study results available
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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.

Conditions

  • Bradyarrhythmia

Interventions

DEVICE

TherapyGuide

Use of TherapyGuide function to help programming the device

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513538 on ClinicalTrials.gov