Arrhythmia Type UnknownNCT02484898
SEEQ™ Performance Study
An observational study of Arrhythmia Type Unknown, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.
Trial summary
The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia Type Unknown
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2015to Aug 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (for example, atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders.
Who may be able to join
- Patient is indicated for a SEEQ™ MCT/ECM System for approved indications
- Patient is 18 years of age or older
- Patient is willing and able to provide consent and authorize the use and disclosure of health information
- Patient is willing and able to comply with the protocol
Who cannot join
- Patient has known allergy and/or hypersensitivity to adhesives or hydrogel.
- Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring.
- Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™
- Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Aurora, Colorado
Study site
Clearwater, Florida
Study site
Henderson, Nevada
Study site
Jackson, Mississippi
Study site
Larkspur, California
Study site
Palm Beach Gardens, Florida
Study site
Rome, Georgia
Study site
Sebring, Florida
Study site
Simi Valley, California
About this study
The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).
- Conditions
- Arrhythmia Type Unknown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SEEQ™ MCT/ECM System | SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield of the SEEQ™ MCT/ECM System
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionAug 2016
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 Arrhythmia Type UnknownStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SEEQ Performance Study Clinical Team, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484898
- Sponsor's protocol ID
- SEEQ™ Performance Study
- Status last verified
- Dec 2015
- First submitted
- 25 Jun 2015
- Last updated
- 22 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEEQ™ Performance Study
- ClinicalTrials.gov ID
- NCT02484898
- Acronym / sponsor ID
- SEEQ™ Performance Study
- Conditions
- Arrhythmia Type Unknown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 22 Nov 2016
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 the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEEQ™ MCT/ECM System | – | –SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (for example, atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders.
Key inclusion criteria (4 listed)
- Patient is indicated for a SEEQ™ MCT/ECM System for approved indications
- Patient is 18 years of age or older
- Patient is willing and able to provide consent and authorize the use and disclosure of health information
- Patient is willing and able to comply with the protocol
Key exclusion criteria (4 listed)
- Patient has known allergy and/or hypersensitivity to adhesives or hydrogel.
- Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring.
- Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™
- Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Yield of the SEEQ™ MCT/ECM System
Time frame: 120 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
SEEQ Performance Study Clinical Team study director
Medtronic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia Type Unknown, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.
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 4 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 22 Nov 2016). 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?
Diagnostic Yield of the SEEQ™ MCT/ECM System (time frame: 120 Days). 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 22 Nov 2016.