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Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

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ClinicalTrials.gov Identifier: NCT00709774
Recruitment Status : Unknown
Verified June 2008 by Osaka General Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2008
Last Update Posted : July 3, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.

Condition or disease Intervention/treatment Phase
Atrio-Ventricular Block Device: Pacemaker Implantation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block
Study Start Date : July 2008
Estimated Primary Completion Date : June 2010
Arms and Interventions

Intervention Details:
    Device: Pacemaker Implantation
    Implantation of right ventricular lead at septal or apex.

Outcome Measures

Primary Outcome Measures :
  1. Hospitalization for the heart failure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. incidence of atrial fibrillation [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the patients who need pacemaker implantation for atrio-ventricular block

Exclusion Criteria:

  • Pregnancy, left ventricular dysfunction at the time of implantation
More Information

Responsible Party: Yoshio Furukawa, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00709774     History of Changes
Other Study ID Numbers: OPaS-SvA
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Atrioventricular Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes