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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01626404
Other study ID # TC-060112
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date February 2016

Study information

Verified date June 2022
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen
France CHU of Nantes Nantes
Germany Hannover Medical Center Hannover
Germany University Clinical Center Tuebingen Tuebingen
Netherlands Erasmus Medical Center Rotterdam
Sweden Karolinska University Hospital Stockholm
United Kingdom University Hospital of South Manchester NHS Trust Manchester

Sponsors (2)

Lead Sponsor Collaborator
Abbott Medical Devices Thoratec Europe Ltd

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF 12 months
Secondary Reasons for non-referral Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation. 12 months
Secondary Patient's reasons Assess patients reasons for declining LVAD/transplant as a treatment option. 12 months
Secondary Actual and predicted 12 month survival 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
Secondary Simple clinical parameters for referral Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time. 12 months
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