At a glance
ClinicalIndex Comparison RecordN/ACompleted· 292 enrolled
Drug / intervention
Ilivia ICD Family +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BIO|MASTER.Ilivia Family / Plexa
In Brief
A clinical study evaluating Ilivia ICD Family and Plexa ICD lead for Heart Failure and Tachyarrhythmia. Completed, enrolled 292 participants across 25 sites in 10 countries.
Detailed Summary
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Tachyarrhythmia
CountriesAustralia, Austria, Denmark, France, Germany, Israel, Latvia, Singapore, Spain, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2016
Primary CompletionDec 2017
Study CompletionMar 2018
TodayJul 2026
First PostedMay 17, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.1 years ago
Interventions
Ilivia ICD Familydevice
pre-defined device programming, measurements and follow-up schedule
Plexa ICD leaddevice
predefined follow-up schedule