Resynchronization Surgery Combined Unified Efficacy

Meshalkin Research Institute of Pathology of Circulation178 enrolled

Overview

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 )

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

178

Conditions

Ischemic Heart Failure

Interventions

Coronary artery bypass graftingPROCEDURE

Standard coronary surgry according guidelines

Epicardial implantation of cardiac resynchronization therapy deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Medical University of Silesia

Katowice, Poland

State Research Institute of Circulation Pathology

Novosibirsk, Russia

University Medical Center

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Long-term mortality

Time frame: 6 years

Secondary Outcomes

Mode of Death

Time frame: 6 years

Adverse cardiac events

Time frame: 6 years

Lead performance

Time frame: 6 years

Data from ClinicalTrials.gov

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