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The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.
"In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "In-Clinic LVAT" | Experimental | All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "In-Clinic LVAT" | Device | Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful"In-Clinic LVAT" Test | The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests. | 0-3 months post inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer | This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit. An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations |
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Inclusion Criteria:
Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]:
Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
Reviewed, signed and dated informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Mansourati, Pr | CHRU de Brest, FRANCE. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Brest | Brest | 29609 | France |
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All the 60 patients were assigned to the treatment arm.
Subjects have been included from Feb 16, 2017 to June 2, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | "In-Clinic LVAT" | 60 patients were included in the single-arm study. The Left Ventricular auto threshold (LVAT) algorithm test was performed at the 2 study visits M0 and M1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | "In-Clinic LVAT" | Single-arm study design: all the 60 patients were assigned to the treatment arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Percentage of Successful"In-Clinic LVAT" Test | The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests. | Complete LV vector test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm. Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered "Successful" if the difference is within ± 2 step | Posted | Number | 95% Confidence Interval | percentage of successful LVAT test | 0-3 months post inclusion | Completed LV vector tests | Completed LV vector tests |
|
0-3 months post inclusion
SAE and device deficiency were collected through the study duration and AE was collected at each study visit.
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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 | In-Clinic LVAT | All serious adverse events and device deficiency during in-clinic LVAT test. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac decompensation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Scientific Communication | Microport CRM | 0677164209 | anne.rousseauplasse@crm.microport.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2016 | Sep 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2018 | Sep 20, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| C535598 | Creatine deficiency, X-linked |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 0-15 days post inclusion |
| Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit | The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint. | 0-15 days post inclusion |
| Percentage of Successful "In-Clinic LVAT" Test at M1 Visit | The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint | 1-3 months after first visit |
| Percentage of Eligible Subjects to LVAT Feature | Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit | 0-3 months post inclusion |
| Safety of the LVAT Algorithm | Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm. | 0-3 months post inclusion |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type of device implanted | Count of Participants | Participants |
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| Secondary | Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer | This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit. An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations | Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm. Accurate LV Vector Test: The LV threshold value provided by the algorithm compared to the reviewer assessment is considered accurate if the difference is within ± 1 step. | Posted | Number | 95% Confidence Interval | Percentage of accurate determination | 0-15 days post inclusion | Number of completed LV Vector Tests | Number of completed LV Vector Tests |
|
|
|
| Secondary | Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit | The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint. | Completed LV vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm. Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered "Successful" if the difference is within ± 2 steps | Posted | Number | 95% Confidence Interval | Percentage of successful LVAT test | 0-15 days post inclusion | Number of completed LV Vector Tests | Number of completed LV Vector Tests |
|
|
|
| Secondary | Percentage of Successful "In-Clinic LVAT" Test at M1 Visit | The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint | Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm. Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered "Successful" if the difference is within ± 2 steps | Posted | Number | 95% Confidence Interval | Pecentage of successful LVAT test | 1-3 months after first visit | Number of completed LV Vector Tests | Number of completed LV Vector Tests |
|
|
|
| Secondary | Percentage of Eligible Subjects to LVAT Feature | Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit | Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits | Posted | Number | Percentage of eligible subjects | 0-3 months post inclusion |
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| Secondary | Safety of the LVAT Algorithm | Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm. | Included population | Posted | Number | Event | 0-3 months post inclusion |
|
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|
| 0 |
| 60 |
| 6 |
| 60 |
| 0 |
| 60 |
| Heart failure worsening | Cardiac disorders | Systematic Assessment |
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| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Embolization | Vascular disorders | Systematic Assessment |
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