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NCT00294034 Clinical Trial

VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies

Bradycardia Clinical Trial

Official title:
VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00294034
Other study ID # 197
Secondary ID
Status Completed
Phase N/A
First received February 16, 2006
Last updated March 26, 2007
Start date October 2002
Est. completion date May 2006

Study information
Verified date March 2007
Source Medtronic Cardiac Rhythm Disease Management
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.

Description:

The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.

Recruitment information / eligibility
Status Completed
Enrollment 950
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

• Class I or Class II indication for dual chamber pacing

Exclusion Criteria:

- Has an ICD or is a known candidate for an ICD

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Device:
• Pacemaker

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Medtronic Cardiac Rhythm Disease Management Medtronic, Medtronic BRC

Country where clinical trial is conducted

United States, 

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