Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia (NCT03001765) | Clinical Trial Compass
CompletedNot Applicable
Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
United States25 participantsStarted 2016-12
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
Timeframe: 12 months or less
2
The total number of all significant arrhythmias detected in the study population.
Timeframe: 12 months or less
3
The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
Timeframe: 12 months or less
4
Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.