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

Suspected Arrhythmia Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001765
• Other study ID #: IMPACT
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: St Elizabeth Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suspected Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
United States	St. Elizabeth Healthcare	Edgewood	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
St Elizabeth Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.	The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings.	12 months or less
Primary	The total number of all significant arrhythmias detected in the study population.	To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation.	12 months or less
Primary	The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.	Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor.	12 months or less
Primary	Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.	Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.	12 months or less
Secondary	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.	In subjects with recurrent symptom, compare the intensive strategy to the number of prior tests that have been performed. In subject who have previously presented with symptoms and undergone prior diagnostic evaluation, estimate the total expense of all prior evaluation and diagnostic testing performed.	12 months or less