Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function|
- Acceptance of TherapyGuide proposals and typology of programming changes [ Time Frame: 30 months ] [ Designated as safety issue: No ]
The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians and to define the most frequent type of modifications done when not accepted.
Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.
- Rationale of programming changes [ Time Frame: 30 months ] [ Designated as safety issue: No ]Describe the rationale of programming changes made on more than 15 % of patients
- Patient profile for which most frequent programming changes were made [ Time Frame: 30 months ] [ Designated as safety issue: No ]Describe, if applicable, the type of patient for which most frequent changes were made
- Update of TherapyGuide function [ Time Frame: 30 months ] [ Designated as safety issue: No ]Describe how the TherapyGuide can be updated using the habits of physicians
- Overall satisfaction of physicians regarding TherapyGuide [ Time Frame: 30 months ] [ Designated as safety issue: No ]A score derived from answers to a qualitative questionnaire will be used to assess the overall satisfaction of physicians on TherapyGuide.
|Study Start Date:||May 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Use of TherapyGuide function to help programming the device
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513538
|Marseille, France, 13006|