Clinical trial NCT00846001: Resynchronization Surgery Combined Unified Efficacy
Official title: Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Failure
Keywords: Resynchronization Therapy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2009-02-18
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with single-step implantation of CRT system (CABG alone vs CABG + CRT )


Eligibility criteria: 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

Primary outcomes:
measure: Long-term mortality
timeFrame: 6 years
Secondary outcomes:
measure: Mode of Death
timeFrame: 6 years
measure: Adverse cardiac events
timeFrame: 6 years
measure: Lead performance
timeFrame: 6 years
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
city: Ljubljana
country: Slovenia
facility: University Medical Center
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokushalov E, Romanov A, Prohorova D, Cherniavsky A, Goscinska-Bis K, Bis J, Bochenek A, Karaskov A. Coronary artery bypass grafting with concomitant cardiac resynchronisation therapy in patients with ischaemic heart failure and left ventricular dyssynchrony. Eur J Cardiothorac Surg. 2010 Dec;38(6):773-80. doi: 10.1016/j.ejcts.2010.03.036. Epub 2010 May 6.
citation: Pokushalov E, Romanov A, Prohorova D, Cherniavsky A, Karaskov A, Gersak B. Coronary artery bypass grafting with and without concomitant epicardial cardiac resynchronization therapy in patients with ischemic cardiomyopathy: a randomized study. Heart Surg Forum. 2010 Jun;13(3):E177-84. doi: 10.1532/HSF98.20091149.
citation: Romanov A, Goscinska-Bis K, Bis J, Chernyavskiy A, Prokhorova D, Syrtseva Y, Shabanov V, Alsov S, Karaskov A, Deja M, Krejca M, Pokushalov E. Cardiac resynchronization therapy combined with coronary artery bypass grafting in ischaemic heart failure patients: long-term results of the RESCUE study. Eur J Cardiothorac Surg. 2016 Jul;50(1):36-41. doi: 10.1093/ejcts/ezv448. Epub 2015 Dec 30.