NCT00292539

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

February 14, 2006

Last Update Submit

April 22, 2009

Conditions

Atrial FibrillationBradycardiaHeart BlockSick Sinus Syndrome

Keywords

PacemakerNYHA classEjection fractionHeart Failure

Interventions

Any pacemaker with right ventricular pacing optionDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kreiskrankenhaus

Viechtach, 94234, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationBradycardiaHeart BlockSick Sinus SyndromeHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System DiseaseArrhythmia, Sinus

Study Officials

  • Sven Treusch, PHD

    Guidant Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 16, 2006

Study Start

February 1, 2006

Study Completion

September 1, 2006

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

DE(1)