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BIO|MASTER.Edora Family Study

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT03091322
Collaborator
(none)
120
Enrollment
11
Locations
33.6
Actual Duration (Months)
10.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

  3. LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).

  4. (S)ADEs and calculation of the SADE free rate until the 6-month follow-up

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
BIO|MASTER.Edora Family Study
Actual Study Start Date :
Feb 12, 2017
Actual Primary Completion Date :
Sep 12, 2019
Actual Study Completion Date :
Dec 2, 2019

Arms and Interventions

Arm 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

Outcome Measures

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. [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 [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 [until the 6-month follow-up]

    Descriptive analysis of all (S)ADEs and calculation of the SADE free rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kepler Universitätsklinikum Linz Austria
2 Maria Heimsuchung - Caritas-Klinik Pankow Berlin Germany
3 Herzzentrum Bernau Bernau Germany 16321
4 Städtisches Klinikum Brandenburg GmbH Brandenburg Germany
5 Klinikum St. Georg gGmbH Leipzig Germany
6 Otto-von-Guericke-Universität Magdeburg Magdeburg Germany
7 Niels-Stensen-Kliniken, Marienhospital Osnabrück Osnabrück Germany
8 Universitätsklinikum Würzburg Würzburg Germany 97080
9 Heinrich-Braun-Klinikum gemeinnützige GmbH Zwickau Germany
10 Clínica Universitaria de Navarra (CUN) Pamplona Spain
11 Luzerner Kantonsspital (LUKS) Luzern Switzerland

Sponsors and Collaborators

  • Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT03091322
Other Study ID Numbers:
  • BA106
First Posted:
Mar 27, 2017
Last Update Posted:
May 12, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 12, 2020