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

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Medtronic

Status

Completed

Conditions

Bradyarrhythmia

Treatments

Device: TherapyGuide

Study type

Observational

Funder types

Industry

Identifiers

NCT01513538
TherapyGuide

Details and patient eligibility

About

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.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

700 participants in 1 patient group

TherapyGuide
Description:
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Treatment:
Device: TherapyGuide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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