Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

LivaNova

Status: Completed

Conditions: Heart Failure

Treatments: Device: "In-Clinic LVAT"

Study type: Interventional

Funder types: Industry

Identifiers

NCT03014180

IPTL01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

"In-Clinic LVAT"

Experimental group

Description:

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.

Treatment:

Device: "In-Clinic LVAT"