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OpenTrials
Completed

NCT Number: NCT00846001

Resynchronization Surgery Combined Unified Efficacy

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 )

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Key information

Conditions

Ischemic Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Silesia, Katowice, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (СABG or PCI) within 12 months of study enrollment
  • Chronic atrial fibrillation

Treatment and study plan

Coronary artery bypass grafting

Procedure

Standard coronary surgry according guidelines

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.

Primary outcomes

  1. Long-term mortality

    Time frame: 6 years

Secondary outcomes

  1. Mode of Death

    Time frame: 6 years

  2. Adverse cardiac events

    Time frame: 6 years

  3. Lead performance

    Time frame: 6 years

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Official study title

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

Acronym: RESCUE

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2009
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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