Clinical trial NCT00273182: InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Official title: InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiomyopathy
Keywords: Heart Failure
Cardiomyopathy
Cardiac pacing
Cardiac resynchronization therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 1999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for use of a cardiac device

Brief summary: 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).

Detailed description: Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.

Eligibility 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

Primary outcomes:
measure: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
timeFrame: 36 month follow-up
Secondary outcomes:
measure: Left Ventricular (LV) Lead R-wave Amplitude
timeFrame: 36 month follow-up
measure: Left Ventricular (LV) Lead Impedance
timeFrame: 36 months follow-up
measure: Left Ventricular (LV) Lead Pacing Voltage Threshold
timeFrame: 36 months follow-up
measure: Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant
timeFrame: 36 months follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Ft. Smith
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Napa
country: United States
state: California
city: Oxnard
country: United States
state: California
city: San Diego
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Washington D.C.
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Rockford
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Worchester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Hattiesburg
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: High Pointe
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Doylestown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Sherman
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Medtronic
name: InSync Registry Study Leader
role: STUDY_CHAIR
References:
citation: Johnson WB, Abraham WT, Young JB, Wheelan K, Smith AL, Chang Y, Brinkman P; InSync Registry Investigators. Long-term performance of the attain model 4193 left ventricular lead. Pacing Clin Electrophysiol. 2009 Sep;32(9):1111-6. doi: 10.1111/j.1540-8159.2009.02451.x.