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OpenTrials
Completed

NCT Number: NCT01626404

Screening for Advanced Heart Failure Treatment (SEE-HF)

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.

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Key information

Conditions

Advanced Heart Failure CRT and/or ICD

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Reasons for non-referral

    Time frame: 12 months

    Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.

  2. Patient's reasons

    Time frame: 12 months

    Assess patients reasons for declining LVAD/transplant as a treatment option.

  3. 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)).

  4. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Europe Ltd

Registry information

Acronym: SEE-HF

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2012
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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