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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01513538
First received: January 11, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Bradyarrhythmia
Device: TherapyGuide

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 700
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TherapyGuide
Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
Device: TherapyGuide
Use of TherapyGuide function to help programming the device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513538

Locations
France
Clinique Bouchard
Marseille, France, 13006
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01513538     History of Changes
Other Study ID Numbers: TherapyGuide
Study First Received: January 11, 2012
Last Updated: December 23, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France : French Data Protection Authority (Commission Nationale de l'Informatique et des Libertés)
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medtronic Bakken Research Center:
Pacemaker programming
Bradyarrhythmia

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014