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

NCT03001765 | Completed DMC

• 1 other identifier: IMPACT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Suspected Arrhythmia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• 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.

  12 months or less

Study Arms (1)

Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac

OTHER

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.

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

Interventions

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

Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Elizabeth Healthcare: lead

Study Sites (1)

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Study Officials

• Thomas P Carrigan, MD, FHRS

  St Elizabeth Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 23, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)