We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626404
First Posted: June 22, 2012
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Europe Ltd )
  Purpose
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.

Condition
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)
Groups/Cohorts
Patients enrolled
All patients enrolled in the study

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626404


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

Responsible Party: Thoratec Europe Ltd
ClinicalTrials.gov Identifier: NCT01626404     History of Changes
Other Study ID Numbers: TC-060112
First Submitted: June 20, 2012
First Posted: June 22, 2012
Last Update Posted: April 19, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases