Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA) (LEVEA)

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: "In-Clinic LVAT"

Detailed Description

"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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: "In-Clinic LVAT"; 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"; Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.; Other Names: Activation of an algorithm in CRT-D device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Jacques Mansourati, Pr, CHRU de Brest, FRANCE.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2017
• Primary Completion (ACTUAL): August 17, 2017
• Study Completion (ACTUAL): August 17, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Heart failure, CRT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IPTL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No