Resynchronization Surgery Combined Unified Efficacy (RESCUE)

This study has been completed.
Sponsor:
Information provided by:
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT00846001
First received: February 16, 2009
Last updated: August 10, 2011
Last verified: August 2011

February 16, 2009
August 10, 2011
September 2007
September 2010   (final data collection date for primary outcome measure)
Null Hypothesis (Ho): There is no survival benefit in the CRT group (CABG-with or without SVR-+ CRT) compared to the control group. H0: Ө ≤ 1. Alternative Hypothesis (Ha): There is a survival benefit in the CRT group. HA: Ө > 1 [ Time Frame: 2007-2011 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00846001 on ClinicalTrials.gov Archive Site
Not Provided
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Resynchronization Surgery Combined Unified Efficacy
Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients

The purpose of the study is to compare survivability of the patients with ischemic heart failure LVEF ≤ 35% after coronary artery bypass grafting or coronary artery bypass grafting combined with surgical ventricular restoration and single-step implantation of CRT system and isolated coronary artery bypass grafting or coronary artery bypass grafting with surgical ventricular restoration. (CABG + CRT or CABG + SVR + CRT vs CABG or CABG + SVR)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Ischemic Heart Failure
Procedure: Coronary artery bypass grafting or coronary artery bypass grafting combined with surgical ventricular restoration and single-step epicardial implantation of CRT
During the cardiac surgery, the CRT arm 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. The second patient group will get only a CABG or CABG+SVR procedure without CRT device implantation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women
  • Age 18-80
  • History of ischemic heart failure and indications for CABG or CABG and SVR
  • 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 heart surgery (CABG or CABG+SVR)
  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Russian Federation,   Slovenia
 
NCT00846001
SACRT 022, RU 001
Yes
Evgeny Pokushalov, State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny A Pokushalov, MD, Prof. State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP