Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA) (NCT03014180) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)
France60 participantsStarted 2017-02-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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