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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01879670
Other study ID # 2012HSB002B
Secondary ID FS/13/34/30173
Status Terminated
Phase N/A
First received June 11, 2013
Last updated October 27, 2015
Start date June 2013
Est. completion date June 2014

Study information

Verified date October 2015
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: National Institute for Health Research
Study type Observational

Clinical Trial Summary

Heart failure is a common condition, and the number of people with advanced disease continues to increase. We need new treatments that improve patients' symptoms and extend life. Recently the new CircuLite Synergy pump has come into use. It is the smallest pump manufactured to date and does not cover the full work of the heart, instead providing "partial" support. One interesting thing about this is that taking some strain off the heart might allow the muscle to repair and rebuild its own strength. This process is called reverse remodelling, and is the topic of this research. Our hypothesis is that "partial" support improves patients' symptoms and causes improvement in heart muscle function. We also want to examine the best techniques for assessing this, including new scanning and molecular tests, and study some practical aspects of the pump to do with blood clotting.


Description:

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Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
CircuLite Synergy left ventricular assist device


Locations

Country Name City State
Belgium Universitaire Ziekenhuizen Leuven Leuven
United Kingdom Royal Brompton & Harefield NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in maximal aerobic exercise capacity (peak VO2) 6 months No
Secondary Change in 6-minute walk distance 6 months No
Secondary Change in New York Heart Association (NYHA) functional class 6 months No
Secondary Change in B-type natriuretic peptide 6 months No
Secondary Change in ventricular dimensions as measured by echocardiography 6 months No
Secondary Change in ventricular strain as measured by echocardiography 6 months No
Secondary Change in circulating microRNA expression profile 6 months No
Secondary Change in ventilatory equivalent for carbon dioxide (VE/VCO2) slope 6 months No
Secondary Change in haemodynamic parameters at right heart catheterisation 6 months No
Secondary Change in quality of life score 6 months No
Secondary Accumulated days of hospital inpatient stay due to cardiovascular reasons 6 months No
Secondary Incidence of significant haematological derangements 6 months No
Secondary Number of participants suffering adverse events 'Adverse events' are defined as major bleeding, thromboembolism, stroke, infection, perioperative complications, right ventricular failure, device-related morbidity and device failure. 6 months Yes
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