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
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
- Congestive Heart Failure
- Heart Disease
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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