BIO|MASTER.Edora Family Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 120
- Locations
- 11
- Primary Endpoint
- (S)ADEs and calculation of the SADE free rate
Study Overview
Brief 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:
- AV Opt feature:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
(S)ADEs and calculation of the SADE free rate
Time Frame: until the 6-month follow-up
Descriptive analysis of all (S)ADEs and calculation of the SADE free rate
Overall score for the usability of the LV VectorOpt feature
Time Frame: until the 1-month follow-up
The LV VectorOpt feature has to be assessed for patients with an HF-T device (triple-chamber) and a QP lead (quadripolar, HF-T QP group) only. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.
Time Frame: until the 1-month follow-up
The AV Opt Feature will be assessed only for patients with triple-chamber devices and patients with dual-chamber devices (if clinically indicated) with sinus rhythm of sufficient intrinsic rate. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
Secondary Outcomes
No secondary outcomes reported