Status:
COMPLETED
Resynchronization Surgery Combined Unified Efficacy
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Collaborating Sponsors:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Ischemic Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00846001
Start Date
September 1 2007
End Date
September 1 2010
Last Update
July 15 2015
Active Locations (3)
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1
Medical University of Silesia
Katowice, Poland
2
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055
3
University Medical Center
Ljubljana, Slovenia