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Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (IDENTIFY-HF)

Primary Purpose

Atrial Fibrillation, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reveal XT® Insertable Cardiac Monitor
Heart Failure Risk Status Diagnostic
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
  • Patient is willing and able to comply with the protocol, including follow-up visits
  • Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
  • Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor
  • Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home
  • Willing and able to transmit data via CareLink

Exclusion Criteria:

  • Patient is pregnant
  • Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures
  • Endstage (Stage D or New York Heart Association class IV) heart failure
  • Asymptomatic (Stage B or New York Heart Association class I) heart failure
  • Severe aortic stenosis or insufficiency
  • Existing insertable cardiac monitor implanted for more than 1 year
  • Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
  • Severe renal impairment (estimated glomerular filtration rate <25mL/min)
  • Myocardial infarction within prior 30 days

Sites / Locations

  • Scripps Green
  • Aurora Denver Cardiology Associates
  • Spectrum Health
  • The Valley Hospital
  • Carolinas Medical Center/Sanger Heart & Vascular
  • The Ohio State University
  • Lancaster Heart & Stroke Foundation
  • Medical University of South Carolina
  • St. Thomas Research Institute
  • University of Texas Southwestern Medical Center
  • Heart Clinic PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control arm

Risk Status Guided

Arm Description

Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.

Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).

Outcomes

Primary Outcome Measures

Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2011
Last Updated
June 12, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01486316
Brief Title
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Acronym
IDENTIFY-HF
Official Title
Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Other
Arm Description
Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.
Arm Title
Risk Status Guided
Arm Type
Experimental
Arm Description
Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).
Intervention Type
Device
Intervention Name(s)
Reveal XT® Insertable Cardiac Monitor
Other Intervention Name(s)
Reveal XT®
Intervention Description
If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).
Intervention Type
Other
Intervention Name(s)
Heart Failure Risk Status Diagnostic
Intervention Description
The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".
Primary Outcome Measure Information:
Title
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
Description
Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score.
Time Frame
0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
Other Pre-specified Outcome Measures:
Title
Correlation of HFRS Status With Actions/Testing
Description
At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms. Because of the small number of subjects randomized, no formal statistical analyses were performed.
Time Frame
6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)
Title
Clinical Status Measures
Description
Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst)) Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate.
Time Frame
0 to 18 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 years of age or older Patient (or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with the protocol, including follow-up visits Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations) Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home Willing and able to transmit data via CareLink Exclusion Criteria: Patient is pregnant Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures Endstage (Stage D or New York Heart Association class IV) heart failure Asymptomatic (Stage B or New York Heart Association class I) heart failure Severe aortic stenosis or insufficiency Existing insertable cardiac monitor implanted for more than 1 year Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device Severe renal impairment (estimated glomerular filtration rate <25mL/min) Myocardial infarction within prior 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IDENTIFY-HF Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Green
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Carolinas Medical Center/Sanger Heart & Vascular
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lancaster Heart & Stroke Foundation
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Heart Clinic PLLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

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