Ischemic Heart Failure
Conditions
Keywords
Resynchronization Therapy
Brief summary
The purpose of the study is to compare survivability and efficacy of the patients with severe ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )
Interventions
PROCEDURECoronary artery bypass grafting
Standard coronary surgry according guidelines
DEVICEEpicardial implantation of cardiac resynchronization therapy device
During the cardiac surgery, the CABG+CRT arm patients will be implanted with epicardial leads to the right atrium, right and left ventricles. Left ventricle leads will be fixed to the posterolateral wall provided that there is no scar or fat tissue (behind and 2-3 cm apical than obtuse marginal artery). Right atrial and right ventricular leads will be fixed in a traditional way. Then the leads will be guided into a preformed pocket (left subclavian region) and connected with the CRT device.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women * Age 18-80 * History of ischemic heart failure and indications for CABG * LVEF less than 35% estimated by echocardiography measured within 3 months of study entry * NYHA and CCS (angina) II-IV functional class * Signs of dyssynchrony (at least one of the following three): QRS \> 120 ms or dyssynchrony based on Doppler-methods (Tissue Tracking and TSI methods) or CARE HF criteria: Aortic pre-ejection delay \>140ms, Interventricular mechanical delay \>40 ms, Delayed activation of postero-lateral LV wall
Exclusion criteria
* Failure to provide informed consent. * Previous cardiac surgery * Non-cardiac illness with a life expectancy of less than 3 year * Non-cardiac illness imposing substantial operative mortality * Previous heart, kidney, liver, or lung transplantation * Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device * Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment * Chronic atrial fibrillation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term mortality | 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Mode of Death | 6 years |
| Adverse cardiac events | 6 years |
| Lead performance | 6 years |
Countries
Poland, Russia, Slovenia
Outcome results
None listed