MedTrace Logo

Resynchronization Surgery Combined Unified Efficacy

NCT00846001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2015-07-15

No results posted yet for this study

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 )

Conditions

  • Ischemic Heart Failure

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    collaborator INDUSTRY

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Evgeny A Pokushalov, MD, PhD, Prof. · State Research Institute of Circulation Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Poland
  • Russia
  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846001 on ClinicalTrials.gov