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.
Advanced Heart Failure
CRT and/or ICD
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Screening for Advanced Heart Failure Treatment (SEE-HF)|
- Proportion of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Reasons for non-referral [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.
- Patient's reasons [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assess patients reasons for declining LVAD/transplant as a treatment option.
- Actual and predicted 12 month survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
All patients enrolled in the study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626404
|Contact: Finn Gustafsson, MD firstname.lastname@example.org|
|Principal Investigator: Finn Gustafsson, MD|
|CHU of Nantes||Recruiting|
|Contact: Jean-Noel Trochu, MD email@example.com|
|Principal Investigator: Jean-Noel Trochu, MD|
|Hannover Medical Center||Recruiting|
|Contact: Jan Schmitto, MD firstname.lastname@example.org|
|Principal Investigator: Jan Schmitto, MD|
|University Clinical Center Tuebingen||Recruiting|
|Contact: David Schibilsky, MD David.Schibilsky@med.uni-tuebingen.de|
|Principal Investigator: David Schibilsky, MD|
|Erasmus Medical Center||Recruiting|
|Contact: Kadir Caliskan, MD email@example.com|
|Principal Investigator: Kadir Caliskan, MD|
|Karolinska University Hospital||Recruiting|
|Contact: Lars Lund, MD firstname.lastname@example.org|
|Principal Investigator: Lars Lund, MD|
|University Hospital of South Manchester NHS Trust||Recruiting|
|Manchester, United Kingdom|
|Contact: Steve Shaw, MD email@example.com|
|Principal Investigator: Steve Shaw, MD|
|Study Director:||Laura Damme, BSN, MPH||Thoratec Europe Limited|