Screening for Advanced Heart Failure Treatment (SEE-HF)

Completed

• Conditions: Advanced Heart Failure; CRT and/or ICD

• Registration Number: NCT01626404
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Study Start: 2012-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients	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

Name	Time	Method
Simple clinical parameters for referral	12 months	Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.
Patient's reasons	12 months	Assess patients reasons for declining LVAD/transplant as a treatment option.
Actual and predicted 12 month survival	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)).
Reasons for non-referral	12 months	Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.

Trial Locations

Locations (7)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Clinical Center Tuebingen; 🇩🇪 Tuebingen, Germany

CHU of Nantes; 🇫🇷 Nantes, France

Hannover Medical Center; 🇩🇪 Hannover, Germany

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University Hospital of South Manchester NHS Trust; 🇬🇧 Manchester, United Kingdom

Rigshospitalet; 🇩🇰 Copenhagen, Denmark