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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.