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

NCT01513538 | Completed Results

• 1 other identifier: TherapyGuide
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradyarrhythmia

Keywords

Pacemaker programming; Bradyarrhythmia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TherapyGuide

Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

Device: TherapyGuide

Interventions

TherapyGuide DEVICE

Use of TherapyGuide function to help programming the device

TherapyGuide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

You may qualify if:

• 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

You may not qualify if:

• \- Unwillingness or inability to provide written consent

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

Clinique Bouchard

Marseille, 13006, France

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Céline This
• Organization: Medtronic

celine.this@medtronic.com

33 6 89 71 90 67

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 20, 2012
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 2, 2025
• Results First Posted: December 18, 2017

Record last verified: 2017-05

Locations

FR (1)