NCT00709774

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

July 3, 2008

Status Verified

June 1, 2008

Enrollment Period

1.9 years

First QC Date

July 1, 2008

Last Update Submit

July 2, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for the heart failure

    6 months

Secondary Outcomes (1)

  • incidence of atrial fibrillation

    6 months

Interventions

Implantation of right ventricular lead at septal or apex.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy, left ventricular dysfunction at the time of implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Last Updated

July 3, 2008

Record last verified: 2008-06