Screening for Advanced Heart Failure Treatment (SEE-HF)

Abbott Medical Devices7 sites in 6 countries99 target enrollmentOctober 2012

ConditionsAdvanced Heart Failure CRT and/or ICD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 99
Locations: 7
Primary Endpoint: Proportion of patients
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

February 2016

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•CRT and or ICD device in place.
•NYHA class III - IV heart failure
•EF \</= 40%
•Patient is an out-patient
•Patient is on optimal medical management as tolerated and as defined by primary care physician.
•Patient has signed an informed consent for data collection.

Exclusion Criteria

•Age \<18 years or \>80 years
•CRT device that has been implanted \< 3 months prior to enrollment
•Coronary revascularization within 3 months prior to enrollment
•Patient only has ICD but has CRT planned
•Non-cardiac disease resulting in life expectancy \< 2 yrs
•Patient is hospitalized or will be hospitalized at this time
•Known diagnosis of dementia
•Patient is currently on dialysis
•Oxygen dependent lung disease
•Previously or currently treated with LVAD or heart transplantation

Outcomes

Primary Outcomes

Proportion of patients

Time Frame: 12 months

Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF \</= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD.