Pacemaker IndicationNCT00916344
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
A study testing EVIA Pacemaker in people with Pacemaker Indication, run by Biotronik SE & Co. KG at 1 site in France.
Trial summary
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker Indication
- What is being tested?
- EVIA Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the indications for pacemaker therapy
- Understand the nature of the procedure
- Give informed consent
- Able to complete all testing required by the clinical protocol
- Available for follow-up visits on a regular basis at the investigational site
Who cannot join
- Meet none of the pacemaker indications
- Meet one or more of the contraindications
- Patients with chronic atrial fibrillation (dual chamber pacemaker only)
- Have a life expectancy of less than six months
- Cardiac surgery in the next six months
- Enrolled in another cardiac clinical investigation
- Have other medical devices that may interact with the implanted pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
- Conditions
- Pacemaker Indication
- Being tested
- EVIA Pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVIA PacemakerDevice
patient has standard indication for pacemaker therapy
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker therapy | Experimental | Not described Receives: Device: EVIA Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.
atrial threshold test: measurable automatically or manually.
Measured: 1 month follow-up completed
Secondary outcomes (1)
Complication Free Rate
Complication free rate (in %):
1 minus(the number of possibly pacemaker related complications divided by the number of patients)
Measured: 1- and 3- month follow-up completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pacemaker IndicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Ritter, Dr., Principal investigator, CHU Bordeaux Haut-Lévêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916344
- Sponsor's protocol ID
- 38-1
- Status last verified
- Oct 2011
- First submitted
- 4 Jun 2009
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker
- ClinicalTrials.gov ID
- NCT00916344
- Acronym / sponsor ID
- 38-1
- Conditions
- Pacemaker Indication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Posted 30 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker therapy | Experimental | Device: EVIA Pacemaker |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the indications for pacemaker therapy
- Understand the nature of the procedure
- Give informed consent
- Able to complete all testing required by the clinical protocol
- Available for follow-up visits on a regular basis at the investigational site
Key exclusion criteria (7 listed)
- Meet none of the pacemaker indications
- Meet one or more of the contraindications
- Patients with chronic atrial fibrillation (dual chamber pacemaker only)
- Have a life expectancy of less than six months
- Cardiac surgery in the next six 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 Pacemakerpatient has standard indication for pacemaker therapy | Device | Pacemaker therapy |
Primary outcome
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
Time frame: 1 month follow-up completed
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
1 secondary outcome
Complication Free Rate
Time frame: 1- and 3- month follow-up completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pacemaker Indication
Not yet recruitingObservational study
AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
Recruiting
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
Heart Failure, Bradycardia
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.
Philippe Ritter, Dr. principal investigator
CHU Bordeaux Haut-Lévêque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVIA Pacemaker in people with Pacemaker Indication, run by Biotronik SE & Co. KG at 1 site in France.
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 5 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 7 Oct 2011. 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 France. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) (time frame: 1 month follow-up completed). 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 7 Oct 2011.