This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Screening for Advanced Heart Failure Treatment (SEE-HF) (SEE-HF)

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Europe Ltd ) Identifier:
First received: June 20, 2012
Last updated: April 15, 2016
Last verified: April 2016
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.

Advanced Heart Failure CRT and/or ICD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Advanced Heart Failure Treatment (SEE-HF)

Resource links provided by NLM:

Further study details as provided by St. Jude Medical ( Thoratec Europe Ltd ):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Reasons for non-referral [ Time Frame: 12 months ]
    Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.

  • Patient's reasons [ Time Frame: 12 months ]
    Assess patients reasons for declining LVAD/transplant as a treatment option.

  • Actual and predicted 12 month survival [ Time Frame: 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 [ Time Frame: 12 months ]
    Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.

Enrollment: 99
Study Start Date: October 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Patients enrolled
All patients enrolled in the study


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients with CRT and/or ICD, EF </= 40% and in NYHA III-IV

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01626404

Copenhagen, Denmark
CHU of Nantes
Nantes, France
Hannover Medical Center
Hannover, Germany
University Clinical Center Tuebingen
Tuebingen, Germany
Erasmus Medical Center
Rotterdam, Netherlands
Karolinska University Hospital
Stockholm, Sweden
United Kingdom
University Hospital of South Manchester NHS Trust
Manchester, United Kingdom
Sponsors and Collaborators
Thoratec Europe Ltd
Study Director: Laura Damme, BSN, MPH Thoratec Europe Limited
  More Information

Responsible Party: Thoratec Europe Ltd Identifier: NCT01626404     History of Changes
Other Study ID Numbers: TC-060112
Study First Received: June 20, 2012
Last Updated: April 15, 2016

Keywords provided by St. Jude Medical ( Thoratec Europe Ltd ):
Thoratec Corporation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 18, 2017