Skip to main content
OpenTrials
Completed

NCT Number: NCT03014180

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Creatine deficiency, X-linked Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest

Brest, 29609, France

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"In-Clinic LVAT"

Device

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

Other names: Activation of an algorithm in CRT-D device

Primary outcomes

  1. Percentage of Successful"In-Clinic LVAT" Test

    Time frame: 0-3 months post inclusion

    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.

Secondary outcomes

  1. Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer

    Time frame: 0-15 days post inclusion

    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

  2. Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit

    Time frame: 0-15 days post inclusion

    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.

  3. Percentage of Successful "In-Clinic LVAT" Test at M1 Visit

    Time frame: 1-3 months after first 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

  4. Percentage of Eligible Subjects to LVAT Feature

    Time frame: 0-3 months post inclusion

    Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit

  5. Safety of the LVAT Algorithm

    Time frame: 0-3 months post inclusion

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

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Official study title

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

Acronym: LEVEA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2017
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.