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

• ClinicalTrials.gov Identifier: NCT01486316
• Recruitment Status: Completed
• First Posted: December 6, 2011
• Results First Posted: July 12, 2018
• Last Update Posted: July 12, 2018
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Heart Failure	Device: Reveal XT® Insertable Cardiac Monitor; Other: Heart Failure Risk Status Diagnostic	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
• Study Start Date: November 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
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".

Outcome Measures

Primary Outcome Measures :

1. Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events [ Time Frame: 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm) ]

   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.

Other Outcome Measures:

1. Correlation of HFRS Status With Actions/Testing [ Time Frame: 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm) ]

   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.

2. Clinical Status Measures [ Time Frame: 0 to 18 months post-implant ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Scripps Green

La Jolla, California, United States, 92037

United States, Colorado

Aurora Denver Cardiology Associates

Aurora, Colorado, United States, 80012

United States, Michigan

Spectrum Health

Grand Rapids, Michigan, United States, 49503

United States, New Jersey

The Valley Hospital

Ridgewood, New Jersey, United States, 07450

United States, North Carolina

Carolinas Medical Center/Sanger Heart & Vascular

Charlotte, North Carolina, United States, 28203

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Lancaster Heart & Stroke Foundation

Lancaster, Pennsylvania, United States, 17602

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Tennessee

St. Thomas Research Institute

Nashville, Tennessee, United States, 37205

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Heart Clinic PLLC

McAllen, Texas, United States, 78503

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Chair: IDENTIFY-HF Team; Medtronic

More Information

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01486316
• Other Study ID Numbers: IDENTIFY-HF
• First Posted: December 6, 2011
• Results First Posted: July 12, 2018
• Last Update Posted: July 12, 2018
• Last Verified: June 2018

Additional relevant MeSH terms:

Heart Failure; Atrial Fibrillation; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes