Pacemaker TherapyNCT03091322
BIO|MASTER.Edora Family Study
An observational study of Pacemaker Therapy and Cardiac Resynchronization Therapy, run by Biotronik SE & Co. KG at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Therapy, Cardiac Resynchronization Therapy
- What is being tested?
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 12 Feb 2017to 2 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for cardiac pacemaker or cardiac resynchronization therapy
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany8 sites
Maria Heimsuchung - Caritas-Klinik Pankow
Berlin
Herzzentrum Bernau
Bernau, 16321
Städtisches Klinikum Brandenburg GmbH
Brandenburg
Klinikum St. Georg gGmbH
Leipzig
Otto-von-Guericke-Universität Magdeburg
Magdeburg
Niels-Stensen-Kliniken, Marienhospital Osnabrück
Osnabrück
Universitätsklinikum Würzburg
Würzburg, 97080
Heinrich-Braun-Klinikum gemeinnützige GmbH
Zwickau
About this study
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.
Read the 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:
- AV Opt feature: The feature's AV delay recommendation was
- used as basis for the device programming or is at least considered to be clinically acceptable or
- other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.
- LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).
- (S)ADEs and calculation of the SADE free rate until the 6-month follow-up
- Being tested
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8Device
Assessment of the AV Opt and LV VectorOpt features
| Study group | Role | What they receive |
|---|---|---|
| SR-T group | single chamber pacemaker Receives: Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8 | |
| DR-T group | dual chamber pacemaker Receives: Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8 | |
| HF-T group | triple chamber pacemaker (IS-1 connector) Receives: 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 Receives: Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: until the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start12 Feb 2017
- Primary completion12 Sep 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091322
- Sponsor's protocol ID
- BA106
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2017
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|MASTER.Edora Family Study
- ClinicalTrials.gov ID
- NCT03091322
- Acronym / sponsor ID
- BA106
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- AV Opt feature: The feature's AV delay recommendation was
- used as basis for the device programming or is at least considered to be clinically acceptable or
- other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.
- LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).
- (S)ADEs and calculation of the SADE free rate until the 6-month follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SR-T group | – | Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8single chamber pacemaker |
| DR-T group | – | Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8dual chamber pacemaker |
| HF-T group | – | Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8triple chamber pacemaker (IS-1 connector) |
| HF-T QP group | – | Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for cardiac pacemaker or cardiac resynchronization therapy
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8Assessment of the AV Opt and LV VectorOpt features | Device | DR-T group, HF-T QP group, HF-T group, SR-T group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Therapy and Cardiac Resynchronization Therapy, run by Biotronik SE & Co. KG at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.