NCT03014180

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	"In-Clinic LVAT"	Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.

Timeline

• Start date: 2017-02-16
• Primary completion: 2017-08-17
• Completion: 2017-08-17
• First posted: 2017-01-09
• Last updated: 2019-05-28
• Results posted: 2019-05-28

Locations

1 site across 1 country: France