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

NCT ID: NCT01513538

Last Updated: 2025-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bradyarrhythmia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TherapyGuide

Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

TherapyGuide

Intervention Type DEVICE

Use of TherapyGuide function to help programming the device

Interventions

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TherapyGuide

Use of TherapyGuide function to help programming the device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Bouchard

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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TherapyGuide

Identifier Type: -

Identifier Source: org_study_id

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