Clinical trial NCT03001765: Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
Official title: Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suspected Arrhythmia
Lead sponsor: St Elizabeth Healthcare
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
timeFrame: 12 months or less
measure: The total number of all significant arrhythmias detected in the study population.
timeFrame: 12 months or less
measure: The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
timeFrame: 12 months or less
measure: Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.
timeFrame: 12 months or less
Secondary outcomes:
measure: 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.
timeFrame: 12 months or less
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
Study officials:
affiliation: St Elizabeth Healthcare
name: Thomas P Carrigan, MD, FHRS
role: PRINCIPAL_INVESTIGATOR
References: