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

• 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

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

Patients with indication for cardiac pacemaker or cardiac resynchronization therapy