BIO|MASTER.Edora Family Study

Completed

• Conditions: Pacemaker Therapy; Cardiac Resynchronization Therapy
• Interventions: Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

• Registration Number: NCT03091322
• Lead Sponsor: Biotronik SE & Co. KG

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

Study Timeline

• Study First Submitted: 2017-01-27
• Study Start: 2017-02-12
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2019-09-12
• Study Completion: 2019-12-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HF-T QP group	Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8	triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family
SR-T group	Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8	single chamber pacemaker
HF-T group	Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8	triple chamber pacemaker (IS-1 connector)
DR-T group	Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8	dual chamber pacemaker

Primary Outcome Measures

Name	Time	Method
(S)ADEs and calculation of the SADE free rate	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	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.	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.

Trial Locations

Locations (11)

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Luzerner Kantonsspital (LUKS); 🇨🇭 Luzern, Switzerland

Herzzentrum Bernau; 🇩🇪 Bernau, Germany

Maria Heimsuchung - Caritas-Klinik Pankow; 🇩🇪 Berlin, Germany

Klinikum St. Georg gGmbH; 🇩🇪 Leipzig, Germany

Niels-Stensen-Kliniken, Marienhospital Osnabrück; 🇩🇪 Osnabrück, Germany

Otto-von-Guericke-Universität Magdeburg; 🇩🇪 Magdeburg, Germany

Heinrich-Braun-Klinikum gemeinnützige GmbH; 🇩🇪 Zwickau, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Clínica Universitaria de Navarra (CUN); 🇪🇸 Pamplona, Spain

Städtisches Klinikum Brandenburg GmbH; 🇩🇪 Brandenburg, Germany