Resynchronization Surgery Combined Unified Efficacy (RESCUE)

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Ischemic Heart Failure

Treatments: Procedure: Coronary artery bypass grafting; Device: Epicardial implantation of cardiac resynchronization therapy device

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00846001

SACRT 022

RU 001

Details and patient eligibility

About

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 )

Enrollment: 178 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

CABG alone

Active Comparator group

Description:

Standard coronary artery bypass grafting according guidelines

Treatment:

Procedure: Coronary artery bypass grafting

CABG+CRT

Experimental group

Description:

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

Treatment:

Device: Epicardial implantation of cardiac resynchronization therapy device

Procedure: Coronary artery bypass grafting