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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.
The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD patients with remote follow-up | Patients implanted with a fully automatic ICD and remotely followed-up. |
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| Measure | Description | Time Frame |
|---|---|---|
| Remote Follow-up as an Alternative to Onsite Visit | Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patient implanted with a sigle- or dual-chamber ICD or a Cardiac Resynchronization-Defibrillator system (CRT-D) and remotely followed-up
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| Name | Affiliation | Role |
|---|---|---|
| Walid Amara, MD | Centre Hospitalier de Montfermeil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Montfermeil | Montfermeil | 93370 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | ICD Patients With Remote Follow-up | Patients implanted with a fully automatic ICD and remotely followed-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD Patients With Remote Follow-up | Patients implanted with a fully automatic ICD and remotely followed-up. |
| 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 | Remote Follow-up as an Alternative to Onsite Visit | Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD | Posted | Count of Participants | Participants | 13 months |
|
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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 | ICD Patients With Remote Follow-up | Patients implanted with a fully automatic ICD and remotely followed-up. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Latifa Foudali | Medtronic | 0155381700 | latifa.foudali@medtronic.com |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 75 |
| 354 |
| 0 |
| 354 |
| Ventricular arrhytmias | Cardiac disorders |
|
| Cardiac decompensation | Cardiac disorders |
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| Atrial arrhytmias | Cardiac disorders |
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| Infection or pocket hematoma | Skin and subcutaneous tissue disorders |
|
| Event of aggravation | Cardiac disorders | dyspnea, heart failure, stroke... |
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| cardiovascular procedures | Cardiac disorders | stent, ablation, transplantation..; |
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| cardiovascular complication | Cardiac disorders | aneurysm, pericarditis, stenosis... |
|
| Non cardiovascular causes | General disorders |
|
| Integrity default of material components | Injury, poisoning and procedural complications |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |