BIO|MASTER.Edora Family Study

Biotronik SE & Co. KG120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Pacemaker Therapy Cardiac Resynchronization Therapy

Interventions

Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8DEVICE

Assessment of the AV Opt and LV VectorOpt features

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Kepler Universitätsklinikum

Linz, Austria

Maria Heimsuchung - Caritas-Klinik Pankow

Berlin, Germany

Herzzentrum Bernau

Bernau, Germany

Städtisches Klinikum Brandenburg GmbH

Outcomes

Primary Outcomes

AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.

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.

Time frame: until the 1-month follow-up

Overall score for the usability of the LV VectorOpt feature

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.

Time frame: until the 1-month follow-up

(S)ADEs and calculation of the SADE free rate

Descriptive analysis of all (S)ADEs and calculation of the SADE free rate

Time frame: until the 6-month follow-up

Data from ClinicalTrials.gov

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