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 because the information has not been verified recently.
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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of atrial fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014