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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Medtronic

Information provided by (Responsible Party):

Medtronic Bakken Research Center

ClinicalTrials.gov Identifier:

NCT01513538

First received: January 11, 2012

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 11, 2012
Last Updated Date	January 16, 2012
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 16, 2012)	Acceptance of TherapyGuide proposals and typology of programming changes [ Time Frame: 30 months ] [ Designated as safety issue: No ] The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians and to define the most frequent type of modifications done when not accepted. Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01513538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 16, 2012)	Rationale of programming changes [ Time Frame: 30 months ] [ Designated as safety issue: No ] Describe the rationale of programming changes made on more than 15 % of patients Patient profile for which most frequent programming changes were made [ Time Frame: 30 months ] [ Designated as safety issue: No ] Describe, if applicable, the type of patient for which most frequent changes were made Update of TherapyGuide function [ Time Frame: 30 months ] [ Designated as safety issue: No ] Describe how the TherapyGuide can be updated using the habits of physicians Overall satisfaction of physicians regarding TherapyGuide [ Time Frame: 30 months ] [ Designated as safety issue: No ] A score derived from answers to a qualitative questionnaire will be used to assess the overall satisfaction of physicians on TherapyGuide.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
Official Title ^ICMJE	TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Condition ^ICMJE	Bradyarrhythmia
Intervention ^ICMJE	Device: TherapyGuide Use of TherapyGuide function to help programming the device
Study Group/Cohort (s)	TherapyGuide Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function Intervention: Device: TherapyGuide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	700
Estimated Completion Date	October 2013
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01513538
Other Study ID Numbers ^ICMJE	TherapyGuide
Has Data Monitoring Committee	No
Responsible Party	Medtronic Bakken Research Center
Study Sponsor ^ICMJE	Medtronic Bakken Research Center
Collaborators ^ICMJE	Medtronic
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Bakken Research Center
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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