NCT00846001

Resynchronization Surgery Combined Unified Efficacy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 )

Conditions

• Ischemic Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Coronary artery bypass grafting	Standard coronary surgry according guidelines
DEVICE	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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-02-18
• Last updated: 2015-07-15

Locations

3 sites across 3 countries: Poland, Russia, Slovenia