Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

LivaNova60 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

"In-Clinic LVAT"DEVICE

Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU Brest

Brest, France

Outcomes

Primary Outcomes

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.

Time frame: 0-3 months post inclusion

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 0-3 months post inclusion

Safety of the LVAT Algorithm

Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.

Data from ClinicalTrials.gov

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