Suspected ArrhythmiaIMPACTNCT03001765
Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
A study testing Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System". in people with Suspected Arrhythmia, run by St Elizabeth Healthcare at 1 site in United States.
Trial summary
Hypothesis: Patients that were previously discharged from the emergency department with a subsequent non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early Reveal LINQ™ Insertable Cardiac Monitoring System placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Arrhythmia
- What is being tested?
- Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Patient present to the ED with symptoms suggestive of cardiac arrhythmia
- English is the patient's primary language
- Willing and able to provide consent for participation in the study
- Patient is willing and able to comply with the protocol including the required follow-up
Who cannot join
- Refusal to participate
- Age < 18 years of age
- Unable to provide consent
- Current implanted loop recorder, or loop recorder explanted within the past 12 months.
- Current implant of cardiac implantable electronic device, such as permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
- Life expectancy < 12 months
Show all 14Show fewer
- History of prior cardiac ablation or electrophysiology study for suspected arrhythmia
- Investigator decision related to serious comorbidities or identification of reversible cause
- Unable to comply with follow-up procedures
- Previous documented diagnosis of cardiac arrhythmia by holter monitor, event monitor, ECG.
- Currently taking antiarrhythmic medication for a previously documented cardiac arrhythmia
- History of or suspected diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
- Patient has unusual thoracic anatomy that precludes proper SEEQ patch placement
- Patient is enrolled in another study that could confound the results of this study
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis:
Patients that were previously discharged from the emergency department with a subsequent non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early Reveal LINQ™ Insertable Cardiac Monitoring System placement.
Primary Study Objectives:
To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™ Insertable Cardiac Monitoring System) in patients with suspected but no previously documented arrhythmias that result in a clinically actionable event.
Read the detailed description
Eligible patients will be enrolled after presentation to the Emergency Department of St. Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the emergency department. Patients will be exited from the study and considered complete at the identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months from enrollment date, whichever occurs first.
Protocol defined endpoints
- Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic resynchronization device.
- Planned cardiac ablation procedure.
- Initiation of medical therapy for the purpose of treating dysrhythmia.
- Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.
- Conditions
- Suspected Arrhythmia
- Being tested
- Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".Other
Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac | Other | Intensive monitoring strategy of discharging from the Emergency Department with an external 30 day cardiac monitoring system. A negative 30 day external monitor report will be followed by an implantable cardiac monitor. Receives: Other: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings.
Measured: 12 months or less
The total number of all significant arrhythmias detected in the study population.
To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation.
Measured: 12 months or less
The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor.
Measured: 12 months or less
Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.
Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.
Measured: 12 months or less
Secondary outcomes (1)
Evaluate if the intensive monitoring strategy causes a reduction in the number and overall expense of ancillary diagnostic testing used to aid in the detection of suspected cardiac arrhythmias.
In subjects with recurrent symptom, compare the intensive strategy to the number of prior tests that have been performed. In subject who have previously presented with symptoms and undergone prior diagnostic evaluation, estimate the total expense of all prior evaluation and diagnostic testing performed.
Measured: 12 months or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected ArrhythmiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Elizabeth Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas P Carrigan, MD, FHRS, Principal investigator, St Elizabeth Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001765
- Sponsor's protocol ID
- IMPACT
- Acronym
- IMPACT
- Status last verified
- Oct 2019
- First submitted
- 16 Dec 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
- ClinicalTrials.gov ID
- NCT03001765
- Acronym / sponsor ID
- IMPACT / IMPACT
- Conditions
- Suspected Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St Elizabeth HealthcareUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 23 Dec 2016 (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.
Hypothesis:
Patients that were previously discharged from the emergency department with a subsequent non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early Reveal LINQ™ Insertable Cardiac Monitoring System placement.
Primary Study Objectives:
To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™ Insertable Cardiac Monitoring System) in patients with suspected but no previously documented arrhythmias that result in a clinically actionable event.
Detailed description
Eligible patients will be enrolled after presentation to the Emergency Department of St. Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the emergency department. Patients will be exited from the study and considered complete at the identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months from enrollment date, whichever occurs first.
Protocol defined endpoints
- Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic resynchronization device.
- Planned cardiac ablation procedure.
- Initiation of medical therapy for the purpose of treating dysrhythmia.
- Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac | Other | Other: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".Intensive monitoring strategy of discharging from the Emergency Department with an external 30 day cardiac monitoring system. A negative 30 day external monitor report will be followed by an implantable cardiac monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- Patient present to the ED with symptoms suggestive of cardiac arrhythmia
- English is the patient's primary language
- Willing and able to provide consent for participation in the study
- Patient is willing and able to comply with the protocol including the required follow-up
Key exclusion criteria (14 listed)
- Refusal to participate
- Age < 18 years of age
- Unable to provide consent
- Current implanted loop recorder, or loop recorder explanted within the past 12 months.
- Current implant of cardiac implantable electronic device, such as permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
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 |
|---|---|---|
| Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result. | Other | Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac |
Primary outcome
Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
Time frame: 12 months or less
The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings.
The total number of all significant arrhythmias detected in the study population.
Time frame: 12 months or less
To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation.
The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
Time frame: 12 months or less
Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor.
Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.
Time frame: 12 months or less
Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.
1 secondary outcome
Evaluate if the intensive monitoring strategy causes a reduction in the number and overall expense of ancillary diagnostic testing used to aid in the detection of suspected cardiac arrhythmias.
Time frame: 12 months or less
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 9 Oct 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Thomas P Carrigan, MD, FHRS principal investigator
St Elizabeth Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System". in people with Suspected Arrhythmia, run by St Elizabeth Healthcare 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 5 inclusion and 14 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 9 Oct 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?
Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy. (time frame: 12 months or less). The study lists 4 primary outcomes in all. 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 9 Oct 2019.