BIO|MASTER.Edora Family Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-12

Study Completion Date

2019-12-02

Brief Summary

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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.

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Detailed Description

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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

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Pacemaker Therapy Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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