Ischaemic cardiomyopathy ischaemic heart failure
Conditions
Interventions
The Revivent device will be used for surgical restoration of left ventricle.
This device can be used to place permanent cardiac implants into the heart for
the reduction of the LV volume in patients
the
Locking Anchor houses a cam-based reversible locking mechanism allowing
apposition of the two anchors at a continuum of positions. Once the proper
distance between the two is established, exces
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The following criteria will be applied for inclusion:;- > 18 years of age - Able to provide written informed consent - Medical history of antero-septal myocardial infarction with a discreet akinetic/dyskinetic scar located in the antero-septal or apical (may extend laterally) regions of the LV - Dilated left ventricle with or without aneurysm - Left ventricular end-systolic volume index (LVESVI) * 60ml/m2 - Left ventricular ejection fraction (LVEF) * 40% - Symptomatic cardiac dysfunction causing heart failure: NYHA class * II - Maintenance on stable medical therapy in accordance with prevailing heart failureguidelines - Mitral valve regurgitation * 1 - With or without cardiac device (ICD/CRT)
Exclusion criteria
Exclusion criteria: Patients are not eligible for the study if they meet the following criteria: ;- Unable or unwilling to provide written informed consent - * 18 years of age - Pregnancy or claustrophobia - Known concomitant disease with a life expectancy of 2 - Intolerance or unwillingness to take Acenocoumarol - Functioning pacemaker leads in antero-apical RV, which would interfere with anchor placement - Pulmonary arterial pressure > 60 mm Hg - Myocardial infarction within 90 days prior to surgery - Chronic renal failure with a serum creatinine > 250 µmol/l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoints are: - Assessment of complications over the course of 1 year - Evaluation of the decrease in LV volume by measuring the LVESVI with MRI/CT, (6) and 12 months after surgery - Evaluation of changes in heart failure status measured by NYHA class, quality of life assessment questionnaire and ergometry/6MWT. These data will be collected at the beginning of the study and at the 6th and 12th month of the follow-up - Compilation of detailed description of ischaemic heart characteristics using MRI (before the procedure , 6 and 12 months postoperatively) or cardiac CT (before and 12 months after the procedure). - MRI/CT quantification of DMF in the non-infarcted myocardium at the beginning and end of the study - Assessment of LVEF improvement with TTE/MRI or CT, prior to surgery and during follow-up - Assessment of any improvement in mitral valve regurgitation within 1 year , measured at several time intervals (preoperatively, intraoperatively, at discharge, and 6 and 12 months postoperatively). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - Gathering of clinical information that is potentially relevant for the study objectives, including comorbidities, fluid status and medication use - Assessment of diastolic function with TTE (preoperatively, at discharge, 6 and 12 months after surgery). - Evaluation of procedure-related ischaemia( ECG alternation and/or increase in CKMB level) intra-operative and for 48 hours postoperatively - Record the biomarker profile ( NT-proBNP, trop I, Gal-3 and creatinine) - 48 hour postoperative Holter monitoring for arrhythmias - Intra-operative documentation of heart characteristics by means of TEE (LV volume, function , mitral valve regurgitation, tethering area, coaptation depth) - Record number of patients with LAA exclusion in combination with SVR. | — |
Countries
Netherlands
Outcome results
None listed