Screening for Advanced Heart Failure Treatment (SEE-HF)

Advanced Heart Failure Clinical Trial

— SEE-HF  

Official title:

Screening for Advanced Heart Failure Treatment (SEE-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626404
• Other study ID #: TC-060112
• Status: Completed
• Start date: October 2012
• Est. completion date: February 2016

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Heart Failure
• CRT and/or ICD
• Heart Failure

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	CHU of Nantes	Nantes
Germany	Hannover Medical Center	Hannover
Germany	University Clinical Center Tuebingen	Tuebingen
Netherlands	Erasmus Medical Center	Rotterdam
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	University Hospital of South Manchester NHS Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Europe Ltd

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients	Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF	12 months
Secondary	Reasons for non-referral	Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.	12 months
Secondary	Patient's reasons	Assess patients reasons for declining LVAD/transplant as a treatment option.	12 months
Secondary	Actual and predicted 12 month survival	Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)).	12 months
Secondary	Simple clinical parameters for referral	Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.	12 months