Screening for Advanced Heart Failure Treatment (SEE-HF)

NCT01626404 | Completed

• 1 other identifier: TC-060112
• Study Type: observational
• Target: 99
• Locations: 6 countries
• Sites: 7

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.

Conditions

Advanced Heart Failure; CRT and/or ICD

Keywords

Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients

  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.

  12 months

Secondary Outcomes (4)

• Reasons for non-referral

  12 months

• Patient's reasons

  12 months

• Actual and predicted 12 month survival

  12 months

• Simple clinical parameters for referral

  12 months

Study Arms (1)

Patients enrolled

All patients enrolled in the study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with CRT and/or ICD, EF \</= 40% and in NYHA III-IV

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Europe Ltd: collaborator

Study Sites (7)

Rigshospitalet

Copenhagen, Denmark

Location

CHU of Nantes

Nantes, France

Location

Hannover Medical Center

Hanover, Germany

Location

University Clinical Center Tuebingen

Tübingen, Germany

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University Hospital of South Manchester NHS Trust

Manchester, United Kingdom

Location

Study Officials

• Pooja Chatterjee

  Thoratec Europe Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

DK (1); NL (1); SE (1); FR (1); GB (1); DE (2)