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

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

This study is not yet open for participant recruitment.
Verified by Osaka General Medical Center, June 2008

Sponsored by:	Osaka General Medical Center
Information provided by:	Osaka General Medical Center
ClinicalTrials.gov Identifier:	NCT00709774

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 IV

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

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:

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

No Contacts or Locations Provided

More Information

Responsible Party:	Osaka General Medical Center ( Yoshio Furukawa )
Study ID Numbers:	OPaS-SvA
First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709774
Health Authority:	Japan: Institutional Review Board

Study placed in the following topic categories:

Ventricular Dysfunction

Heart Diseases

Heart Block

Ventricular Dysfunction, Left

Atrioventricular Block

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008