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

Suspected Arrhythmia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Suspected Arrhythmia

• NCT number: NCT03001765
• Study type: Interventional
• Source: St Elizabeth Healthcare
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Completion date: September 2018