Resynchronization Surgery Combined Unified Efficacy

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT00846001
• Date of registration: 16/02/2009
• Prospective Registration: No
• Primary sponsor: Meshalkin Research Institute of Pathology of Circulation
• Public title: Resynchronization Surgery Combined Unified Efficacy RESCUE
• Scientific title: Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients
• Date of first enrolment: September 2007
• Target sample size: 178
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00846001
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Poland, Russian Federation, Slovenia

Contacts

• Name: Evgeny A Pokushalov, MD, PhD, Prof.
• Affiliation: State Research Institute of Circulation Pathology

Key inclusion & exclusion 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 (?ABG or PCI) within 12 months of study
enrollment

- Chronic atrial fibrillation



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ischemic Heart Failure

Intervention(s)

Procedure: Coronary artery bypass grafting

Device: Epicardial implantation of cardiac resynchronization therapy device

Primary Outcome(s)

Long-term mortality [Time Frame: 6 years]

Secondary Outcome(s)

Mode of Death [Time Frame: 6 years]

Adverse cardiac events [Time Frame: 6 years]

Lead performance [Time Frame: 6 years]

Secondary ID(s)

RU 001

SACRT 022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic Bakken Research Center