Bradyarrhythmia
Conditions
Keywords
Pacemaker programming, Bradyarrhythmia
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.
Interventions
DEVICETherapyGuide
Use of TherapyGuide function to help programming the device
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of TherapyGuide Proposals and Typology of Programming Changes | 30 months | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TherapyGuide Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
TherapyGuide: Use of TherapyGuide function to help programming the device | 578 |
| Total | 578 |
Baseline characteristics
| Characteristic | TherapyGuide |
|---|---|
| Age, Customized Men | 77 years |
| Age, Customized Women | 79 years |
| Region of Enrollment France | 578 participants |
| Sex/Gender, Customized Men | 347 participants |
| Sex/Gender, Customized Women | 231 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 30 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Implanted With a Dual Chamber Pacemaker | Acceptance of TherapyGuide Proposals and Typology of Programming Changes | 46 percentage of patients |