CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 700 enrolled
Drug / intervention
TherapyGuidedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01513538
NCT01513538N/ACompleted

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

Medtronic Cardiac Rhythm and Heart Failure·observational·Posted Jan 20, 2012·Updated Jul 2, 2025

In Brief

An observational study evaluating TherapyGuide for Bradyarrhythmia. Completed, enrolled 700 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBradyarrhythmia
CountriesFrance
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2012
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago

Interventions

TherapyGuidedevice

Use of TherapyGuide function to help programming the device