Cardiac Pacemaker, ArtificialNCT03049722
Clinical Investigation Plan for the AVOPT Data Collection Clinical Study
A study testing Pacemaker in people with Cardiac Pacemaker, Artificial, run by Biotronik Canada Inc at 2 sites in Canada.
Trial summary
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Pacemaker, Artificial
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
- Possessing 1st or 3rd degree AV block
- Implanted with Biotronik bipolar RA and RV leads
- Implantation date should be at least 4 months prior to this study
Who cannot join
- Patient is a minor (18 years old or younger)
- Patient is pregnant or breast-feeding
- Patient does not have the legal capacity to provide consent
- Patient has Mobitz type I or Mobitz type II heart block
- Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
- Patient is participating in other clinical studies during the clinical study
- Patient is strictly pacemaker dependent (physician discretion)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Rouge Valley Centenary
Scarborough Village, Ontario, M1E 4B9
CHUS - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
About this study
Official title: Clinical Investigation Plan for the AVOPT Data Collection
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.
- Conditions
- Cardiac Pacemaker, Artificial
- Being tested
- Pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
| Study group | Role | What they receive |
|---|---|---|
| AVOPT Patient | Experimental | Not described Receives: Device: Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation analysis between measured PWD and optimal AVD.
Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startFeb 2015
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacemaker, ArtificialStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik Canada Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049722
- Sponsor's protocol ID
- AVOPT
- Status last verified
- Feb 2017
- First submitted
- 14 Mar 2016
- Last updated
- 10 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan for the AVOPT Data Collection
- ClinicalTrials.gov ID
- NCT03049722
- Acronym / sponsor ID
- AVOPT
- Conditions
- Cardiac Pacemaker, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotronik Canada IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Feb 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.
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVOPT Patient | Experimental | Device: Pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
- Possessing 1st or 3rd degree AV block
- Implanted with Biotronik bipolar RA and RV leads
- Implantation date should be at least 4 months prior to this study
Key exclusion criteria (7 listed)
- Patient is a minor (18 years old or younger)
- Patient is pregnant or breast-feeding
- Patient does not have the legal capacity to provide consent
- Patient has Mobitz type I or Mobitz type II heart block
- Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
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 | Device | AVOPT Patient |
Primary outcome
Correlation analysis between measured PWD and optimal AVD.
Time frame: Up to 6 hours
Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment.
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 10 Feb 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker in people with Cardiac Pacemaker, Artificial, run by Biotronik Canada Inc at 2 sites in Canada.
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 4 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Correlation analysis between measured PWD and optimal AVD. (time frame: Up to 6 hours). 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 10 Feb 2017.