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

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ClinicalTrials.gov Identifier: NCT01513538
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Brief 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.


Condition or disease Intervention/treatment
Bradyarrhythmia Device: TherapyGuide

Study Type : Observational
Actual Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
Actual Study Start Date : May 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Group/Cohort Intervention/treatment
TherapyGuide
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Device: TherapyGuide
Use of TherapyGuide function to help programming the device




Primary Outcome Measures :
  1. Acceptance of TherapyGuide Proposals and Typology of Programming Changes [ Time Frame: 30 months ]

    The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians.

    Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513538


Locations
France
Clinique Bouchard
Marseille, France, 13006
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01513538     History of Changes
Other Study ID Numbers: TherapyGuide
First Posted: January 20, 2012    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: May 2017

Keywords provided by Medtronic Bakken Research Center:
Pacemaker programming
Bradyarrhythmia

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes