Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

Heart Failure Clinical Trial

— LEVEA  

Official title:

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014180
• Other study ID #: IPTL01
• Status: Completed
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: August 17, 2017

Study information

• Verified date: September 2018
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• "In-Clinic LVAT"
Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety of the LVAT Algorithm	Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.	0-3 months post inclusion