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

NCT ID: NCT03001765

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-09-30

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.

Conditions

Suspected Arrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Elizabeth Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas P Carrigan, MD, FHRS

Role: PRINCIPAL_INVESTIGATOR

St Elizabeth Healthcare

Locations

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Countries

United States

Other Identifiers

IMPACT

Identifier Type: -

Identifier Source: org_study_id