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

TherapyGuide : 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 Overview

• Status: Completed
• Conditions: Bradyarrhythmia
• Intervention / Treatment: Device: TherapyGuide

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13006
    • Clinique Bouchard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of TherapyGuide Proposals and Typology of Programming Changes	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.	30 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 16, 2012
• First Posted (Estimated): January 20, 2012

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Bradyarrhythmia; Pacemaker programming
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: TherapyGuide