Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

Study Overview
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Brief Summary
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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.

Detailed Description
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In-Clinic LVAT feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups: first visit: planned to be conducted 15 days maximum after inclusion second visit: planned to be conducted between 1 and 3 months after the first visit The evaluation consists in the comparison between the threshold value provided by the algorithm and the threshold value obtained manually by the physician.

Official Title
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Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

Conditions
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Heart Failure

Intervention / Treatment
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* Device: In-Clinic LVAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]: With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or; With IS4 Platinium SonR CRT-D (model 1844, CE-marked). 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: Subject included in another clinical study that could confound the results of this study; Malfunction or dislodgment of right atrial, right and left ventricular implanted leads; Subject diagnosed with permanent atrial fibrillation; Known pregnancy; Minor age; Under protection or guardianship; Unavailability for scheduled follow-up or refusal to cooperate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Clinic LVAT<br>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. | Device: In-Clinic LVAT<br>* Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.<br>* Other names: Activation of an algorithm in CRT-D device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of SuccessfulIn-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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, CRT