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

June 23, 2022 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • France
      • Nantes, France
        • CHU of Nantes
  • Germany
      • Hannover, Germany
        • Hannover Medical Center
      • Tuebingen, Germany
        • University Clinical Center Tuebingen
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus Medical Center
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Manchester, United Kingdom
        • University Hospital of South Manchester NHS trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients enrolled
All patients enrolled in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for non-referral
Time Frame: 12 months
Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.
12 months
Patient's reasons
Time Frame: 12 months
Assess patients reasons for declining LVAD/transplant as a treatment option.
12 months
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)).
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Europe Ltd

Investigators

  • Study Director: Pooja Chatterjee, Thoratec Europe Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-060112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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