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

Bradyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513538
• Other study ID #: TherapyGuide
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: May 22, 2017
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Intervention

Device:
• TherapyGuide
Use of TherapyGuide function to help programming the device

Locations

Country	Name	City	State
France	Clinique Bouchard	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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