Clinical trial NCT03091322: BIO|MASTER.Edora Family Study
Official title: BIO|MASTER.Edora Family Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker Therapy
Cardiac Resynchronization Therapy
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for cardiac pacemaker or cardiac resynchronization therapy

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.
timeFrame: until the 1-month follow-up
measure: Overall score for the usability of the LV VectorOpt feature
timeFrame: until the 1-month follow-up
measure: (S)ADEs and calculation of the SADE free rate
timeFrame: until the 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Berlin
country: Germany
facility: Maria Heimsuchung - Caritas-Klinik Pankow
city: Bernau
country: Germany
facility: Herzzentrum Bernau
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg GmbH
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken, Marienhospital Osnabrück
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum gemeinnützige GmbH
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra (CUN)
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital (LUKS)
Study officials:
References: