Other Clinical Trial - BIO|MASTER.Edora Family Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study Design

- Open-label, prospective, non-randomized, multicenter, international

- about 13 study sites

Study Endpoints

The following endpoints are defined and will be assessed with descriptive analysis:

1. AV Opt feature:

The feature's AV delay recommendation was

1. used as basis for the device programming or is at least considered to be clinically acceptable or

2. other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.

2. LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).

3. (S)ADEs and calculation of the SADE free rate until the 6-month follow-up ;

Study Design

Related Conditions & MeSH terms

Cardiac Resynchronization Therapy
Pacemaker Therapy

Clinical Trial Details

NCT number	NCT03091322
Study type	Observational
Source	Biotronik SE & Co. KG
Contact
Status	Completed
Phase
Start date	February 12, 2017
Completion date	December 2, 2019

View Details

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