NCT03001765

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: St Elizabeth Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-12-23
• Last updated: 2019-10-09

Locations

1 site across 1 country: United States