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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00709774
Other study ID # OPaS-SvA
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received July 1, 2008
Last updated July 2, 2008
Start date July 2008

Study information

Verified date June 2008
Source Osaka General Medical Center
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy, left ventricular dysfunction at the time of implantation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Pacemaker Implantation
Implantation of right ventricular lead at septal or apex.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Osaka General Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Hospitalization for the heart failure 6 months No
Secondary incidence of atrial fibrillation 6 months No
See also
  Status Clinical Trial Phase
Completed NCT02400983 - Real Life Automatic Atrial Capture Device Control N/A
Completed NCT00832260 - IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.