NCT03091322

BIO|MASTER.Edora Family Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pacemaker Therapy
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8	Assessment of the AV Opt and LV VectorOpt features

Timeline

• Start date: 2017-02-12
• Primary completion: 2019-09-12
• Completion: 2019-12-02
• First posted: 2017-03-27
• Last updated: 2020-05-12

Locations

11 sites across 4 countries: Austria, Germany, Spain, Switzerland