BIO|MASTER.Edora Family Study

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 12, 2019

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

Interventions

  • Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
    • Assessment of the AV Opt and LV VectorOpt features

Arms, Groups and Cohorts

  • SR-T group
    • single chamber pacemaker
  • DR-T group
    • dual chamber pacemaker
  • HF-T group
    • triple chamber pacemaker (IS-1 connector)
  • HF-T QP group
    • triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • (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

Participating in This Clinical Trial

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 MonitoringĀ® concept; – Age ā‰„ 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotronik SE & Co. KG
  • Provider of Information About this Clinical Study
    • Sponsor

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