Status:
TERMINATED
Partial Left Ventricular Support in Advanced Heart Failure
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Heart Failure
Heart-Assist Devices
Eligibility:
All Genders
18-80 years
Brief 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 Circ...
Detailed Description
The CircuLite Synergy pump is a new minimally-invasive partial support left ventricular assist device (LVAD) that pumps blood from the left atrium to the right subclavian artery. Ex vivo pilot data su...
Eligibility Criteria
Inclusion
- Patients with ischaemic or dilated cardiomyopathy aged 18 to 80 years.
- Symptoms categorised by INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) at level 3-6 despite optimal tolerated medical therapy. Practically this includes patients who are in hospital or managing at home with substantial dependence on hospital care.
- Peak VO2 \<15ml/kg/min with respiratory exchange ratio\>1 on cardiopulmonary exercise testing OR a 6-minute walking distance \<300m OR inability to perform an exercise test due to the severity of heart failure.
- Informed consent obtained prior to entering the study.
Exclusion
- Cause of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or active myocarditis
- Body surface area \<1.2M2 or \>2.3M2, or body mass index \>32 kg/M2.
- Severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume in 1 second \<50% of predicted.
- History of pulmonary hypertension with maintained pulmonary vascular resistance measured \> 4 Wood units or transpulmonary gradient \>14mmHg.
- Pregnancy.
- Evidence of intrinsic hepatic disease defined as liver enzyme levels \> 5 times the upper limit of normal within 4 days before enrolment, severe liver dysfunction, cirrhosis or portal hypertension.
- Occurrence of stroke within 90 days before enrolment.
- Impairment of cognitive function or presence of any form of irreversible dementia.
- Recent history of psychiatric disease (including severe drug or alcohol abuse) that is likely to impair compliance with the study protocol.
- Platelet count \<50 x103mm3 within 24 hours before enrolment.
- Creatinine clearance \< 30ml/min.
- High probability of non-compliance.
- The patient is deemed unsuitable by the clinical team for other reasons.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01879670
Start Date
June 1 2013
End Date
June 1 2014
Last Update
October 28 2015
Active Locations (2)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
2
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP