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

November 4, 2011
November 8, 2013
November 2011
December 2014   (final data collection date for primary outcome measure)
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.
Risk status burden [ Time Frame: Implant 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.
Complete list of historical versions of study NCT01486316 on ClinicalTrials.gov Archive Site
  • 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
  • Heart failure risk status hazard ratio [ Time Frame: Implant 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: Implant to 18 months ] [ Designated as safety issue: No ]
    Characterize the change in six minute hallwalk distance over time in each arm
  • Blood Pressure [ Time Frame: Implant 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: Implant to 18 months ] [ Designated as safety issue: No ]
    Characterize the change in Brain Natriuretic Peptide level (pg/mL) over time in each arm
Not Provided
Not Provided
 
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Atrial Fibrillation
  • Heart Failure
  • 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".

  • 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.
    Interventions:
    • Device: Reveal XT® Insertable Cardiac Monitor
    • Other: Heart Failure Risk Status Diagnostic
  • 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).
    Interventions:
    • Device: Reveal XT® Insertable Cardiac Monitor
    • Other: Heart Failure Risk Status Diagnostic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: IDENTIFY-HF Clinical Trial Leader 800-328-2518 ext 61528 medtronicCRMtrials@medtronic.com
United States
 
NCT01486316
IDENTIFY-HF
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: IDENTIFY-HF Team Medtronic
Medtronic Cardiac Rhythm Disease Management
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP