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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01513538
Other study ID # TherapyGuide
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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