Indication for Cardiac Resynchronization Therapy (CRT)NCT01545739
Evia/Entovis HF-T Master Study
An observational study of Indication for Cardiac Resynchronization Therapy (CRT), run by Biotronik SE & Co. KG at 1 site in Hungary.
Trial summary
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for Cardiac Resynchronization Therapy (CRT)
- What is being tested?
- Evia/Entovis HF-T pacemaker for CRT therapy
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 1 siteHungary
- Study dates
- Apr 2012to Dec 2013
- 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 CRT therapy
Who may be able to join
- Standard indication for CRT therapy
- Legal capacity and ability to consent
- Signed patient informed consent
Who cannot join
- Contraindication for CRT therapy
- ICD indication
- Age < 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Participating in another clinical study of an investigational cardiac drug or device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Master Study of the Evia/Entovis HF-T Pacemaker
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.
- Being tested
- Evia/Entovis HF-T pacemaker for CRT therapy
- Keywords
- Pacemaker therapy, Cardiac resynchronisation therapy (CRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evia/Entovis HF-T pacemaker for CRT therapyDevice
Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| CRT pacemaker implantation | Not described Receives: Device: Evia/Entovis HF-T pacemaker for CRT therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Serious Adverse Device Effect (SADE) free rate
While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%.
Measured: Until 3 month follow-up
Efficacy of the left ventricular capture control feature (focus on threshold measurements)
Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.
Measured: At pre-hospital discharge, 1 and 3 month follow-up
Secondary outcomes (1)
Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)
Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%.
Measured: 1 and 3 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 posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Cardiac Resynchronization Therapy (CRT)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 122 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
- NCT01545739
- Sponsor's protocol ID
- 57
- Status last verified
- Oct 2014
- First submitted
- 1 Mar 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the Evia/Entovis HF-T Pacemaker
- ClinicalTrials.gov ID
- NCT01545739
- Acronym / sponsor ID
- 57
- Keywords
- Pacemaker therapy, Cardiac resynchronisation therapy (CRT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- 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.
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT pacemaker implantation | – | Device: Evia/Entovis HF-T pacemaker for CRT therapy |
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 CRT therapy
Key inclusion criteria (3 listed)
- Standard indication for CRT therapy
- Legal capacity and ability to consent
- Signed patient informed consent
Key exclusion criteria (7 listed)
- Contraindication for CRT therapy
- ICD indication
- Age < 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
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 |
|---|---|---|
| Evia/Entovis HF-T pacemaker for CRT therapyImplantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months | Device | CRT pacemaker implantation |
Primary outcome
Safety: Serious Adverse Device Effect (SADE) free rate
Time frame: Until 3 month follow-up
While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%.
Efficacy of the left ventricular capture control feature (focus on threshold measurements)
Time frame: At pre-hospital discharge, 1 and 3 month follow-up
Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.
1 secondary outcome
Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)
Time frame: 1 and 3 month follow-up
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 16 Oct 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Cardiac Resynchronization Therapy (CRT), run by Biotronik SE & Co. KG at 1 site in Hungary.
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 3 inclusion and 7 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
Safety: Serious Adverse Device Effect (SADE) free rate (time frame: Until 3 month follow-up). The study lists 2 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 16 Oct 2014.