Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Heart Failure Clinical Trial

— IDENTIFY-HF  

Official title:

Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486316
• Other study ID #: IDENTIFY-HF
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: June 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

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:
• 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".

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of HFRS Status With Actions/Testing	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.	6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)
Other	Clinical Status Measures	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.	0 to 18 months post-implant
Primary	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)