BIO|MASTER.Edora Family Study

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 Overview

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

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Kepler Universitätsklinikum
• Germany
  • Berlin, Germany
    • Maria Heimsuchung - Caritas-Klinik Pankow
  • Bernau, Germany, 16321
    • Herzzentrum Bernau
  • Brandenburg, Germany
    • Städtisches Klinikum Brandenburg GmbH
  • Leipzig, Germany
    • Klinikum St. Georg gGmbH
  • Magdeburg, Germany
    • Otto-von-Guericke-Universität Magdeburg
  • Osnabrück, Germany
    • Niels-Stensen-Kliniken, Marienhospital Osnabrück
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
  • Zwickau, Germany
    • Heinrich-Braun-Klinikum gemeinnützige GmbH
• Spain
  • Pamplona, Spain
    • Clínica Universitaria de Navarra (CUN)
• Switzerland
  • Luzern, Switzerland
    • Luzerner Kantonsspital (LUKS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for cardiac pacemaker or cardiac resynchronization therapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SR-T group; single chamber pacemaker	Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8; Assessment of the AV Opt and LV VectorOpt features
DR-T group; dual chamber pacemaker	Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8; Assessment of the AV Opt and LV VectorOpt features
HF-T group; triple chamber pacemaker (IS-1 connector)	Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8; Assessment of the AV Opt and LV VectorOpt features
HF-T QP group; triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family	Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8; Assessment of the AV Opt and LV VectorOpt features

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	until the 6-month follow-up

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2017
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BA106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No