BIO|MASTER.Edora Family Study

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:

• AV Opt feature:

The feature's AV delay recommendation was

• used as basis for the device programming or is at least considered to be clinically acceptable or
• other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.
• LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).
• (S)ADEs and calculation of the SADE free rate until the 6-month follow-up

Inclusion criteria

• Standard indication for pacemaker therapy or cardiac resynchronization therapy
• Patient is able to understand the nature of the study;
• Patient provides written informed consent;
• Patient is able and willing to complete the planned follow-up visits at the investigational site;
• Patient accepts Home Monitoring® concept;
• Age ≥ 18 years.

Exclusion criteria

• Any contraindication for pacemaker or cardiac resynchronization therapy (whichever applies);
• Patient has received or is planned to receive an epicardial LV lead implant;
• Pregnant or breast-feeding;
• Life expectancy of less than 6 months;
• Participation in an interventional clinical investigation