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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01486316
First received: November 4, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Heart Failure
Device: Reveal XT® Insertable Cardiac Monitor
Other: Heart Failure Risk Status Diagnostic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Risk status burden [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The risk status burden is the amount of time a patient spends in a pre-defined risk state, for example at a "Very High" risk of a heart failure event.


Secondary Outcome Measures:
  • Heart failure risk status hazard ratio [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Hazard ratio of heart failure risk group to normal heart failure status for number of heart hospitalizations out of the number of evaluations.

  • Six Minute Hallwalk Distance [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    Characterize the change in six minute hallwalk distance over time in each arm

  • Blood Pressure [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Characterize "High" or "Very High" heart failure risk status correlation to blood pressure

  • Brain Natriuretic Peptide Level (pg/mL) [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    Characterize the change in Brain Natriuretic Peptide level (pg/mL) over time in each arm


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control arm
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.
Device: Reveal XT® Insertable Cardiac Monitor
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).
Other Name: Reveal XT®
Other: Heart Failure Risk Status Diagnostic

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".

Experimental: Risk Status Guided
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).
Device: Reveal XT® Insertable Cardiac Monitor
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).
Other Name: Reveal XT®
Other: Heart Failure Risk Status Diagnostic

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486316

Contacts
Contact: IDENTIFY-HF Clinical Trial Leader 800-328-2518 ext 61528 medtronicCRMtrials@medtronic.com

Locations
United States, California
Scripps Green Recruiting
La Jolla, California, United States, 92037
United States, Colorado
Aurora Denver Cardiology Associates Recruiting
Aurora, Colorado, United States, 80012
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Mid-America Heart Institute Withdrawn
Kansas City, Missouri, United States, 64111
United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
United States, North Carolina
Carolinas Medical Center/Sanger Heart & Vascular Recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Doylestown Cardiology Associates/Central Bucks Withdrawn
Doylestown, Pennsylvania, United States, 18901
Lancaster Heart & Stroke Foundation Recruiting
Lancaster, Pennsylvania, United States, 17602
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
St. Thomas Research Institute Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Heart Clinic PLLC Not yet recruiting
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: IDENTIFY-HF Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01486316     History of Changes
Other Study ID Numbers: IDENTIFY-HF
Study First Received: November 4, 2011
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014