Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure

NCT00814840 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-04-13

No results posted yet for this study

Summary

The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in cardiac capacity and patients' functional status in subjects with congestive heart failure and a physiologic (sinus) rhythm.

Conditions

Interventions

DEVICE

Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads

Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)

DEVICE

Triple-site cardiac resynchronization

Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with three intraventricular leads: one in the right ventricle and two in the left ventricle (via the coronary sinus). Two left ventricular leads connected with Y-connector (Lead Adaptor 2827, Medtronic, Minneapolis, MN, USA)

Sponsors & Collaborators

  • Silesian Centre for Heart Diseases

    lead OTHER

Principal Investigators

  • Radosław Lenarczyk, M.D. · First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

  • Zbigniew Kalarus, M.D. · First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-07-31
Completion
2015-01-31

Countries

  • Poland

Study Locations

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Entities

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 NCT00814840 on ClinicalTrials.gov