Status:
COMPLETED
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 fai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01486316
Start Date
November 1 2011
End Date
February 1 2015
Last Update
July 12 2018
Active Locations (11)
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1
Scripps Green
La Jolla, California, United States, 92037
2
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
3
Spectrum Health
Grand Rapids, Michigan, United States, 49503
4
The Valley Hospital
Ridgewood, New Jersey, United States, 07450