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

Completed

• Conditions: Bradyarrhythmia
• Interventions: Device: TherapyGuide

• Registration Number: NCT01513538
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2016-05-25
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Results First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TherapyGuide	TherapyGuide	Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

Primary Outcome Measures

Name	Time	Method
Acceptance of TherapyGuide Proposals and Typology of Programming Changes	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.

Trial Locations

Locations (1)

Clinique Bouchard; 🇫🇷 Marseille, France