Resynchronization Surgery Combined Unified Efficacy

Ischemic Heart Failure Clinical Trial

— RESCUE  

Official title:

Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846001
• Other study ID #: SACRT 022
• Secondary ID: RU 001
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2009
• Last updated: July 14, 2015
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 (?ABG or PCI) within 12 months of study enrollment

• Chronic atrial fibrillation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Ischemic Heart Failure

Intervention

Procedure:
• Coronary artery bypass grafting
Standard coronary surgry according guidelines

Device:
• Epicardial implantation of cardiac resynchronization therapy 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.

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Katowice
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
Slovenia	University Medical Center	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Medtronic Bakken Research Center

Countries where clinical trial is conducted

Poland,  Russian Federation,  Slovenia, 

References & Publications (2)

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 dyssynchr — View 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 F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term mortality		6 years	Yes
Secondary	Mode of Death		6 years	Yes
Secondary	Adverse cardiac events		6 years	Yes
Secondary	Lead performance		6 years	Yes

External Links

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