Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
IDENTIFY-HF
Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
1 other identifier
interventional
24
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Nov 2011
Typical duration for not_applicable atrial-fibrillation
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
July 12, 2018
CompletedJuly 12, 2018
June 1, 2018
3.1 years
November 4, 2011
May 1, 2015
June 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
Other Outcomes (2)
Correlation of HFRS Status With Actions/Testing
6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)
Clinical Status Measures
0 to 18 months post-implant
Study Arms (2)
Control arm
OTHERSubjects 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.
Risk Status Guided
EXPERIMENTALStudy 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).
Interventions
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).
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".
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Scripps Green
La Jolla, California, 92037, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Carolinas Medical Center/Sanger Heart & Vascular
Charlotte, North Carolina, 28203, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, 17602, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
St. Thomas Research Institute
Nashville, Tennessee, 37205, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Heart Clinic PLLC
McAllen, Texas, 78503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachael Rose, Clinical Research Specialist
- Organization
- Medtronic, Inc
Study Officials
- STUDY CHAIR
IDENTIFY-HF Team
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2011
First Posted
December 6, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
July 12, 2018
Results First Posted
July 12, 2018
Record last verified: 2018-06