Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia (IMPACT)

St Elizabeth Healthcare

Status: Completed

Conditions: Suspected Arrhythmia

Treatments: Other: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".

Study type: Interventional

Funder types: Other

Identifiers

NCT03001765

IMPACT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac

Other group

Description:

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.

Treatment:

Other: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".