Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02026635

Acronym

CONFIRM-HF

Enrollment

Registered

2014-01-03

Start date

2013-09-30

Completion date

2015-02-28

Last updated

2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, Optivol® cardiac device, Medtronic CareLink

Brief summary

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years of age * Admission for worsening of HF * Discharged to home * Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment * Enrolled in Carelink® system and able to transmit data * Able to participate for at least 3 months

Exclusion criteria

* Post heart transplant or actively listed * End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support * Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2) * Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen * Severe pulmonary hypertension not due to left-sided HF

Design outcomes

Primary

Measure	Time frame	Description
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions	90 days from enrollment	Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.

Secondary

Measure	Time frame	Description
Heart Failure Clinical Events	90 days from enrollment	Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.
Assess Patient-Reported Quality of Life	90 days from enrollment	Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Countries

United States

Outcome results