Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 24
- Locations
- 11
- Primary Endpoint
- Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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:
- •Admission with primary diagnosis of HF
- •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
Outcomes
Primary Outcomes
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.