BIO|MASTER.Edora Family Study

May 11, 2020 updated by: Biotronik SE & Co. KG
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitatsklinikum Wurzburg
      • Zwickau, Germany
        • Heinrich-Braun-Klinikum gemeinnützige GmbH
  • Spain
      • Pamplona, Spain
        • Clinica Universitaria de Navarra (CUN)
  • Switzerland
      • Luzern, Switzerland
        • Luzerner Kantonsspital (LUKS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
until the 1-month follow-up
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.
until the 1-month follow-up
(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
until the 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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