An observational study in Pacemaker Therapy and Cardiac Resynchronization Therapy, sponsored by Biotronik SE & Co. KG. Completed at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by Biotronik SE & Co. KG · Observational
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.
Study Design
Study Endpoints
The following endpoints are defined and will be assessed with descriptive analysis:
AV Opt feature:
The feature's AV delay recommendation was
Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with indication for cardiac pacemaker or cardiac resynchronization therapy
Exclusion Criteria:
single chamber pacemaker
Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
dual chamber pacemaker
Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
triple chamber pacemaker (IS-1 connector)
Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family
Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
Assessment of the AV Opt and LV VectorOpt features
AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.
The AV Opt Feature will be assessed only for patients with triple-chamber devices and patients with dual-chamber devices (if clinically indicated) with sinus rhythm of sufficient intrinsic rate. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
Time frame: until the 1-month follow-up
Overall score for the usability of the LV VectorOpt feature
The LV VectorOpt feature has to be assessed for patients with an HF-T device (triple-chamber) and a QP lead (quadripolar, HF-T QP group) only. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
Time frame: until the 1-month follow-up
(S)ADEs and calculation of the SADE free rate
Descriptive analysis of all (S)ADEs and calculation of the SADE free rate
Time frame: until the 6-month follow-up
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Biotronik SE & Co. KG