NCT03091322

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

February 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

May 12, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

January 27, 2017

Last Update Submit

May 11, 2020

Conditions

Pacemaker TherapyCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

SR-T group

single chamber pacemaker

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

DR-T group

dual chamber pacemaker

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

HF-T group

triple chamber pacemaker (IS-1 connector)

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

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

Interventions

Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8DEVICE

Assessment of the AV Opt and LV VectorOpt features

DR-T groupHF-T QP groupHF-T groupSR-T group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indication for cardiac pacemaker or cardiac resynchronization therapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kepler Universitätsklinikum

Linz, Austria

Location

Maria Heimsuchung - Caritas-Klinik Pankow

Berlin, Germany

Location

Herzzentrum Bernau

Bernau, 16321, Germany

Location

Städtisches Klinikum Brandenburg GmbH

Brandenburg, Germany

Location

Klinikum St. Georg gGmbH

Leipzig, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany

Location

Niels-Stensen-Kliniken, Marienhospital Osnabrück

Osnabrück, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Heinrich-Braun-Klinikum gemeinnützige GmbH

Zwickau, Germany

Location

Clínica Universitaria de Navarra (CUN)

Pamplona, Spain

Location

Luzerner Kantonsspital (LUKS)

Lucerne, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

March 27, 2017

Study Start

February 12, 2017

Primary Completion

September 12, 2019

Study Completion

December 2, 2019

Last Updated

May 12, 2020

Record last verified: 2020-01

Locations

ES(1)AU(1)DE(8)CH(1)