System Longevity Study: Monitoring Long-Term Function of Medtronic Heart-Related Products - Full Text View

System Longevity Study: Monitoring Long-Term Function of Medtronic Heart-Related Products (SLS)

This study is currently recruiting participants.

Verified by Medtronic Cardiac Rhythm Disease Management, December 2007

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00271180

Purpose

The main purpose of the System Longevity Study is to monitor the long-term function of Medtronic heart-related products. This study follows individuals who have specific Medtronic heart-related products for as long as the individual has these products and continues to participate in the study.

Condition	Intervention
Arrhythmia Bradycardia Heart Failure Sinus Tachycardia	Device: Various

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	System Longevity Study

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	15000
Study Start Date:	January 1983

Intervention Details:

Monitoring of MDT Leads/generators

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Subject has a new, active Medtronic market-released lead whose enrollment limit has not been achieved and either a pacemaker, defibrillator, or cardiac resynchronization therapy device
Subject received the new lead within a predetermined length of time, typically 6 months
Subject plans to receive follow-up care at a study center

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271180

Contacts

Contact: Medtronic CRM Clinical Trials

medtroniccrmtrials@medtronic.com

Show 30 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Study Chair:

System Longevity Study Leader

Medtronic

More Information

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	602
Study First Received:	December 28, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00271180
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Cardiac Pacing
Implantable Cardioverter Defibrillator
pacemaker
Sinus Bradycardia

Study placed in the following topic categories:

Tachycardia, Supraventricular
Tachycardia, Sinus
Heart Failure
Heart Diseases

Tachycardia
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009