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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Osaka General Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00709774
First Posted: July 3, 2008
Last Update Posted: July 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Osaka General Medical Center
  Purpose
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 Intervention Phase
Atrio-Ventricular Block Device: Pacemaker Implantation Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Osaka General Medical Center:

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

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

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pacemaker Implantation
    Implantation of right ventricular lead at septal or apex.
  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Yoshio Furukawa, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00709774     History of Changes
Other Study ID Numbers: OPaS-SvA
First Submitted: July 1, 2008
First Posted: July 3, 2008
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