Screening for Advanced Heart Failure Treatment (SEE-HF)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01626404

Acronym

SEE-HF

Enrollment

Registered

2012-06-22

Start date

2012-10-31

Completion date

2016-02-29

Last updated

2022-06-24

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

Conditions

Advanced Heart Failure, CRT and/or ICD

Keywords

Thoratec Corporation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients	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.

Secondary

Measure	Time frame	Description
Reasons for non-referral	12 months	Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.
Patient's reasons	12 months	Assess patients reasons for declining LVAD/transplant as a treatment option.
Actual and predicted 12 month survival	12 months	Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)).
Simple clinical parameters for referral	12 months	Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.

Countries

Denmark, France, Germany, Netherlands, Sweden, United Kingdom

Outcome results