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

Primary Purpose

Suspected Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".
Sponsored by
St Elizabeth Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Suspected Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Elizabeth Healthcare

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 16, 2016
Last Updated
October 7, 2019
Sponsor
St Elizabeth Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03001765
Brief Title
Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
Acronym
IMPACT
Official Title
Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Elizabeth Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic resynchronization device. Planned cardiac ablation procedure. Initiation of medical therapy for the purpose of treating dysrhythmia. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Arrhythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
Description
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.
Time Frame
12 months or less
Title
The total number of all significant arrhythmias detected in the study population.
Description
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.
Time Frame
12 months or less
Title
The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
Description
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.
Time Frame
12 months or less
Title
Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.
Description
Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.
Time Frame
12 months or less
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months or less

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Carrigan, MD, FHRS
Organizational Affiliation
St Elizabeth Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

Learn more about this trial

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

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