InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry - Full Text View

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00273182

Purpose

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.

When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).

Condition
Heart Failure Cardiomyopathy

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	March 2002
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort Changes in patient outcome from CRT use

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients indicated for use of a cardiac device

Criteria

Inclusion Criteria:

Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.

Exclusion Criteria:

Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync Registry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273182

Show 57 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Study Chair:

InSync Registry Study Leader

Medtronic

More Information

Responsible Party:	Medtronic CRDM Clinical ( Paula Brinkman )
Study ID Numbers:	187
Study First Received:	January 4, 2006
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00273182
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Heart Failure
Cardiomyopathy
Cardiac pacing
Cardiac resynchronization therapy

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009