Clinical trial NCT01486316: Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Official title: Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
timeFrame: 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
Secondary outcomes:
Other outcomes:
measure: Correlation of HFRS Status With Actions/Testing
timeFrame: 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)
measure: Clinical Status Measures
timeFrame: 0 to 18 months post-implant
Locations:
city: La Jolla
country: United States
facility: Scripps Green
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center/Sanger Heart & Vascular
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Heart & Stroke Foundation
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: McAllen
country: United States
facility: Heart Clinic PLLC
state: Texas
Study officials:
affiliation: Medtronic
name: IDENTIFY-HF Team
role: STUDY_CHAIR
References: