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
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|
|Study Type :||Observational|
|Actual Enrollment :||700 participants|
|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|
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Use of TherapyGuide function to help programming the device
- 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.
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
|Marseille, France, 13006|