Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/25/2018 |
| Start Date: | December 2016 |
| End Date: | July 2019 |
| Contact: | Cynthia T Mulcahy, BSN |
| Email: | cynthia.mulcahy@stelizabeth.com |
| Phone: | 859-301-4725 |
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.
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.
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
1. Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic
resynchronization device.
2. Planned cardiac ablation procedure.
3. Initiation of medical therapy for the purpose of treating dysrhythmia.
4. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.
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
1. Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic
resynchronization device.
2. Planned cardiac ablation procedure.
3. Initiation of medical therapy for the purpose of treating dysrhythmia.
4. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.
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
We found this trial at
1
site
Edgewood, Kentucky 41017
Principal Investigator: Thomas Carrigan, MD
Phone: 859-301-4735
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