Prospective Registry of Pacemaker Patients Concerning Per... | NCT00292539

Studies
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class

NCT00292539

Sponsor

Guidant Corporation

Status

Completed

Last Update Posted

Apr 23, 2009Estimated

Enrollment

600

Phase

Not provided

Conditions

Atrial Fibrillation
Bradycardia
Heart Block
Sick Sinus Syndrome

Interventions

Any pacemaker with right ventricular pacing option

Countries

Germany

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 16, 2006Estimated

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

Apr 22, 2009

Last Update Posted Date

Apr 23, 2009Estimated

Description Module

Brief Summary

This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be documented.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
Any pacemaker with right ventricular pacing option	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Implanted pacemaker for more than 6 months, VVI/DDD, written consent

Exclusion Criteria:

Pacemaker implanted for less than 6 months, no right ventricular pacing possibility (AAI), no consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Treusch, PHD	Guidant Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kreiskrankenhaus		Viechtach		94234	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D001919	Bradycardia
D006327	Heart Block
D012804	Sick Sinus Syndrome
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided