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BIO|MASTER.Edora Family Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091322
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pacemaker Therapy Cardiac Resynchronization Therapy 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

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIO|MASTER.Edora Family Study
Actual Study Start Date : February 12, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2020

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. (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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with indication for cardiac pacemaker or cardiac resynchronization therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091322


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

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT03091322     History of Changes
Other Study ID Numbers: BA106
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No