Resynchronization Surgery Combined Unified Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-09-30

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 )

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Detailed Description

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Conditions

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Ischemic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CABG alone

Standard coronary artery bypass grafting according guidelines

Group Type ACTIVE_COMPARATOR

Coronary artery bypass grafting

Intervention Type PROCEDURE

Standard coronary surgry according guidelines

CABG+CRT

Standard coronary artery bypass grafting according guidelines with concomitant three bipolar epicardial leads implantation for cardiac resynchronization therapy

Group Type EXPERIMENTAL

Coronary artery bypass grafting

Intervention Type PROCEDURE

Standard coronary surgry according guidelines

Epicardial implantation of cardiac resynchronization therapy device

Intervention Type 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.

Interventions

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Coronary artery bypass grafting

Standard coronary surgry according guidelines

Intervention Type PROCEDURE

Epicardial 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No