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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TherapyGuide | Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TherapyGuide | Device | Use of TherapyGuide function to help programming the device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
- Unwillingness or inability to provide written consent
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Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bouchard | Marseille | 13006 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Implanted With a Dual Chamber Pacemaker | All the enrolled patients were patients implanted with a dual chamber pacemaker with the Therapy Guide application : one-arm study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TherapyGuide | Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function TherapyGuide: Use of TherapyGuide function to help programming the device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of patients | 30 months |
|
|
No adverse event collection.
No adverse event collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Implanted With a Dual Chamber Pacemaker | All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Céline This | Medtronic | 33 6 89 71 90 67 | celine.this@medtronic.com |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| years |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| 0 |
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| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |