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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:
Information provided by:
Osaka General Medical Center
ClinicalTrials.gov Identifier:
NCT00709774
First received: July 1, 2008
Last updated: July 2, 2008
Last verified: June 2008
  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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: July 1, 2008
Last Updated: July 2, 2008

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

ClinicalTrials.gov processed this record on April 21, 2017