CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Acticor/Rivacor ICDs/CRT-Ds +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.

Search/NCT03891329
NCT03891329N/ACompleted

BIO|MASTER.Cor Family Study

Biotronik SE & Co. KG·interventional·Posted Mar 27, 2019·Updated Sep 27, 2024

In Brief

A clinical study evaluating Acticor/Rivacor ICDs/CRT-Ds and Plexa S DX for Heart Failure and Tachyarrhythmia. Completed, enrolled 130 participants across 13 sites in 7 countries.

Detailed Summary

Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Hungary, Latvia, Netherlands, Slovakia, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartApr 30, 2019
Primary CompletionDec 21, 2020
Study CompletionSep 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.3 years ago

Interventions

Acticor/Rivacor ICDs/CRT-Dsdevice

pre-defined device programming, measurements and follow-up schedule

Plexa S DXdevice

Implantation, measurements and follow-up schedule