Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-05-31

Brief Summary

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The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.

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Detailed Description

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The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases.

The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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remote patient's management

scheduled remote CareLink data transmission

Intervention Type BEHAVIORAL

Other Intervention Names

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home monitoring

Eligibility Criteria

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Inclusion Criteria

* Subject with a history of at least one heart failure (HF) hospitalization (as defined in the European Society of Cardiology or American College of Cardiology/American Heart Association guidelines), emergency department (ED) visit, or urgent office visit necessitating intravenous (IV) diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 15 days prior to device implant
* Subject has an implanted Reveal® XT device (less than 15 days post implant);
* Ejection Fraction (EF) less than 40 percent
* Patient with access to a telephone line
* Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties
* Age greater than 18 years old
* Patient is willing and able to comply with the Clinical Investigation plan and willing to remain available for follow-up visit, through study closure
* Patient (or patient's legally authorized representative) is willing and able to sign and date the study Informed Consent

Exclusion Criteria

* New York Heart Association (NYHA) Class IV (chronic or ambulatory)
* Planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
* Patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
* Severe chronic obstructive pulmonary disorder (COPD)
* Chronic Atrial Fibrillation at time of enrollment
* ST segment elevation at time of electrocardiogram
* Cognitive disease
* Pregnancy or childbearing potential and not on reliable contraceptive
* Anticipated compliance problem or participation in another competitive trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No