N/A N=60 Treatment

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03014180 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

May 2019

Primary outcome: Primary: Percentage of Successful"In-Clinic LVAT" Test — 94.66 percentage of successful LVAT test

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: "In-Clinic LVAT" (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LivaNova
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Successful"In-Clinic LVAT" Test	94.66	—
SECONDARY Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer	99.31	—
SECONDARY Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit	90.86	—
SECONDARY Percentage of Successful "In-Clinic LVAT" Test at M1 Visit	92.03	—
SECONDARY Percentage of Eligible Subjects to LVAT Feature	98.25	—
SECONDARY Safety of the LVAT Algorithm	6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03014180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.