Right Ventricular Septal Pacing for the Prevention of Lef... | NCT00709774

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

NCT00709774

Sponsor

Osaka General Medical Center

Status

Unknown status

Last Update Posted

Jul 3, 2008Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Atrio-Ventricular Block

Interventions

Pacemaker Implantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2008

Last Update Posted Date

Jul 3, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker Implantation	Device	Implantation of right ventricular lead at septal or apex.

Measure	Description	Time Frame
Hospitalization for the heart failure		6 months

Measure	Description	Time Frame
incidence of atrial fibrillation		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the patients who need pacemaker implantation for atrio-ventricular block

Exclusion Criteria:

Pregnancy, left ventricular dysfunction at the time of implantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided