Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

NCT ID: NCT03014180

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2017-08-17

Brief Summary

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

"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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"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.

Group Type: EXPERIMENTAL

"In-Clinic LVAT"

Intervention Type: DEVICE

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

Interventions

"In-Clinic LVAT"

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

Intervention Type: DEVICE

Other Intervention Names

Activation of an algorithm in CRT-D device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Mansourati, Pr

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest, FRANCE.

Locations

CHRU Brest

Brest, , France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IPTL01

Identifier Type: -

Identifier Source: org_study_id