Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

NCT03014180 | Completed Results

• 1 other identifier: IPTL01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure, CRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  0-15 days post inclusion

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

  0-15 days post inclusion

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

  1-3 months after first visit

• Percentage of Eligible Subjects to LVAT Feature

  0-3 months post inclusion

• Safety of the LVAT Algorithm

  0-3 months post inclusion

Study Arms (1)

"In-Clinic LVAT"

EXPERIMENTAL

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"

Interventions

"In-Clinic LVAT" DEVICE

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

Also known as: Activation of an algorithm in CRT-D device

"In-Clinic LVAT"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Sites (1)

CHRU Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director of Scientific Communication
• Organization: Microport CRM

anne.rousseauplasse@crm.microport.com

0677164209

Study Officials

• Jacques Mansourati, Pr

  CHRU de Brest, FRANCE.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: January 9, 2017
• Study Start: February 16, 2017
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)