Resynchronization Surgery Combined Unified Efficacy (RESCUE)
This study has been completed.
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
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
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Purpose
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)
Condition | Intervention | Phase |
---|---|---|
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 |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Official Title: | Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients |
Resource links provided by NLM:
Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:
Primary Outcome Measures:
- 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 ]
Estimated Enrollment: | 250 |
Study Start Date: | September 2007 |
Study Completion Date: | September 2010 |
Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846001
Locations
Poland | |
Medical University of Silesia | |
Katowice, Poland | |
Russian Federation | |
State Research Institute of Circulation Pathology | |
Novosibirsk, Russian Federation, 630055 | |
Slovenia | |
University Medical Center | |
Ljubljana, Slovenia |
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: | Evgeny A Pokushalov, MD, Prof. | State Research Institute of Circulation Pathology |
More Information
Publications:
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
Publications:
Responsible Party: | Evgeny Pokushalov, State Research Institute of Circulation Pathology |
ClinicalTrials.gov Identifier: | NCT00846001 History of Changes |
Other Study ID Numbers: | SACRT 022, RU 001 |
Study First Received: | February 16, 2009 |
Last Updated: | August 10, 2011 |
Health Authority: | Russia: Ethics Committee |
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Resynchronization Therapy |
Additional relevant MeSH terms:
Heart Failure Ischemia Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 26, 2012