ArrhythmiasEVENCT00919087
Non Invasive Arrhythmia Detection in Hospital Settings
An observational study of Arrhythmias, run by Corventis, Inc..
Trial summary
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Avivo System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Aug 2009
- 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: electrophysiology (EP) study or implantable cardioverter defibrillator (ICD) implant Patients
Who may be able to join
- Is female or male, 18 years of age or older
- Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study with ventricular arrhythmia induction
Who cannot join
- Is participating in another clinical study that may confound the results of this study
About this study
Official title: Evaluating Ventricular Events With Adherent Patient Monitoring Study
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.
Read the detailed description
The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.
- Conditions
- Arrhythmias
- Being tested
- Avivo System
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avivo SystemDevice
Also called external monitoring systems
Non invasive external monitoring deive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corventis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Imad Libbus, PhD, Study director, Corventis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919087
- Sponsor's protocol ID
- COR-2009-002
- Acronym
- EVE
- Status last verified
- Feb 2010
- First submitted
- 10 Jun 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Ventricular Events With Adherent Patient Monitoring Study
- ClinicalTrials.gov ID
- NCT00919087
- Acronym / sponsor ID
- EVE / COR-2009-002
- Conditions
- Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Corventis, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Jun 2009 (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.
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.
Detailed description
The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- electrophysiology (EP) study or implantable cardioverter defibrillator (ICD) implant Patients
Key inclusion criteria (2 listed)
- Is female or male, 18 years of age or older
- Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study with ventricular arrhythmia induction
Key exclusion criteria (1 listed)
- Is participating in another clinical study that may confound the results of this study
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 |
|---|---|---|
| Avivo SystemAlso: external monitoring systemsNon invasive external monitoring deive | Device | – |
Primary outcome
Not reported in the source record.
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 4 Feb 2010.
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ACORYS AI4AF PILOT STUDY
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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.
Imad Libbus, PhD study director
Corventis, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, run by Corventis, Inc..
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 2 inclusion and 1 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 4 Feb 2010.