Resynchronization Surgery Combined Unified Efficacy

Study Overview
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Brief Summary
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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 )

Official Title
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Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients

Conditions
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Ischemic Heart Failure

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting
* Device: Epicardial implantation of cardiac resynchronization therapy device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG alone<br>Standard coronary artery bypass grafting according guidelines | Procedure: Coronary artery bypass grafting<br>* Standard coronary surgry according guidelines<br>|
| Experimental: CABG+CRT<br>Standard coronary artery bypass grafting according guidelines with concomitant three bipolar epicardial leads implantation for cardiac resynchronization therapy | Procedure: Coronary artery bypass grafting<br>* Standard coronary surgry according guidelines<br>Device: Epicardial implantation of cardiac resynchronization therapy device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term mortality |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of Death |  | 6 years | 
| Adverse cardiac events |  | 6 years | 
| Lead performance |  | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resynchronization Therapy