Pacemaker DddNCT03338946
Evaluation of CIED "Readers" for Disease Management
An observational study of Pacemaker Ddd and ICD, run by Edward Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Ddd, ICD
- What is being tested?
- CIED interrogation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 16 Jul 2019
- 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: Subjects being seen in Edward ED, HF clinic or inpatient units being evaluated for HF, TIA/stroke or syncope
Who may be able to join
- have a Medtronic CIED compatible with Medtronic CareLink Express
- being evaluated for heart failure, TIA/stroke or syncope
- able to read and speak English
Who cannot join
- -CIED from other than Medtronic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management
The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.
Read the detailed description
Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.
- Conditions
- Pacemaker Ddd, ICD
- Being tested
- CIED interrogation
- Keywords
- Remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIED interrogationDevice
Also called Remote monitoring
CareLink Express interrogation
| Study group | Role | What they receive |
|---|---|---|
| CIED subjects | CIED interrogation Receives: Device: CIED interrogation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope
percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing
Measured: one day
Secondary outcomes (1)
Average number of minutes from transmission to analysis
number of minutes from CareLink Express interrogation to analysis
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start5 Apr 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DddStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Gifford, Edward Hospital
- Investigators
- Janet Gifford, MSN, Principal investigator, Edward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338946
- Sponsor's protocol ID
- Edward Hospital
- Status last verified
- Jul 2019
- First submitted
- 7 Nov 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management
- ClinicalTrials.gov ID
- NCT03338946
- Acronym / sponsor ID
- Edward Hospital
- Conditions
- Pacemaker Ddd, ICD
- Keywords
- Remote monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Edward HospitalUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 9 Nov 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 evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.
Detailed description
Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIED subjects | – | Device: CIED interrogationCIED interrogation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects being seen in Edward ED, HF clinic or inpatient units being evaluated for HF, TIA/stroke or syncope
Key inclusion criteria (3 listed)
- have a Medtronic CIED compatible with Medtronic CareLink Express
- being evaluated for heart failure, TIA/stroke or syncope
- able to read and speak English
Key exclusion criteria (1 listed)
- -CIED from other than Medtronic
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 |
|---|---|---|
| CIED interrogationAlso: Remote monitoringCareLink Express interrogation | Device | CIED subjects |
Primary outcome
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope
Time frame: one day
percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing
1 secondary outcome
Average number of minutes from transmission to analysis
Time frame: one day
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 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Pacemaker Ddd
RecruitingObservational study
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
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RecruitingObservational study
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
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Left Bundle Branch Area Mapping for Conduction System Pacing
Left Bundle-Branch Block, Pacemaker DDD
Active, not recruitingPhase 4
The Leadless AV Versus DDD Pacing Study
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Danish Randomized Trial on Leadless vs Transvenous Pacing
AV Block
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.
Janet Gifford, MSN principal investigator
Edward Hospital
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 Pacemaker Ddd and ICD, run by Edward Hospital at 1 site 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 3 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 18 Jul 2019. 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 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?
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?
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope (time frame: one day). 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 18 Jul 2019.