Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Not Applicable

Completed

Conditions: Atrial Fibrillation
Heart Failure

Interventions: Device: Reveal XT® Insertable Cardiac Monitor
Other: Heart Failure Risk Status Diagnostic

Registration Number: NCT01486316

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk Status Guided	Heart Failure Risk Status Diagnostic	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).
Control arm	Reveal XT® Insertable Cardiac Monitor	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.
Control arm	Heart Failure Risk Status Diagnostic	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.
Risk Status Guided	Reveal XT® Insertable Cardiac Monitor	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).

Primary Outcome Measures

Name	Time	Method
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (11): The Ohio State University
🇺🇸
Columbus, Ohio, United States
St. Thomas Research Institute
🇺🇸
Nashville, Tennessee, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
Scripps Green
🇺🇸
La Jolla, California, United States
Aurora Denver Cardiology Associates
🇺🇸
Aurora, Colorado, United States
Carolinas Medical Center/Sanger Heart & Vascular
🇺🇸
Charlotte, North Carolina, United States
Lancaster Heart & Stroke Foundation
🇺🇸
Lancaster, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Heart Clinic PLLC
🇺🇸
McAllen, Texas, United States