Resynchronization Surgery Combined Unified Efficacy

NCT00846001 | Completed Phase 3 DMC

• 2 other identifiers: SACRT 022RU 001
• Study Type: interventional
• Target: 178
• Locations: 3 countries
• Sites: 3

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 )

Conditions

Ischemic Heart Failure

Keywords

Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Long-term mortality

  6 years

Secondary Outcomes (3)

• Mode of Death

  6 years

• Adverse cardiac events

  6 years

• Lead performance

  6 years

Study Arms (2)

CABG alone

ACTIVE COMPARATOR

Standard coronary artery bypass grafting according guidelines

Procedure: Coronary artery bypass grafting

CABG+CRT

EXPERIMENTAL

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

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

Interventions

Coronary artery bypass grafting PROCEDURE

Standard coronary surgry according guidelines

CABG alone; CABG+CRT

Epicardial implantation of cardiac resynchronization therapy device 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.

CABG+CRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (3)

Medical University of Silesia

Katowice, Poland

Location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

University Medical Center

Ljubljana, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 20447832 RESULT

• 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.

  PMID: 20534420 RESULT

• 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.

  PMID: 26719401 DERIVED

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Evgeny A Pokushalov, MD, PhD, Prof.

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

SL (1); RU (1); PL (1)