Clinical trial NCT00271544: Attain Model 4196 Left Ventricular (LV) Lead
Official title: Attain Model 4196 Left Ventricular (LV) Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
cardiac pacing
left ventricular lead
cardiac resynchronization therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-01-02
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).


Eligibility criteria: Inclusion Criteria:

* QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
* Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
* Subject has moderate to severe heart failure despite medications

Exclusion Criteria:

* Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
* Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
* Subjects that have had certain surgeries on their heart within the past three months
* Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Primary outcomes:
measure: Safety (Subjects Without a Model 4196 Lead Related Complication)
timeFrame: One Month
measure: Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
timeFrame: One Month
measure: Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
timeFrame: Three Months
Secondary outcomes:
measure: Subjects Successfully Implanted With Model 4196 Lead
timeFrame: Implant
measure: Subjects Successfully Implanted After Cannulation
timeFrame: Implant
measure: All Left Ventricular Leads
timeFrame: Implant
measure: All Medtronic Left Ventricular Leads (Attain Family)
timeFrame: Implant
measure: Cannulation Time
timeFrame: Implant
measure: Fluoroscopy Time
timeFrame: Implant
measure: Model 4196 Lead Placement Time
timeFrame: Implant
measure: Total Implant Time
timeFrame: Implant
measure: Assessment of Lead Handling Characteristics
timeFrame: Implant
measure: Electrical Performance - Tip Electrode: Sensing
timeFrame: 12-month
measure: Electrical Performance - Tip Electrode: LV Voltage Threshold
timeFrame: 12-month
measure: Electrical Performance -Tip Electrode: Pacing Impedance
timeFrame: 12-month
measure: Electrical Performance -Ring Electrode: Sensing
timeFrame: Implant
measure: Electrical Performance - Ring Electrode: LV Voltage Threshold
timeFrame: 12-month
measure: Electrical Performance -Ring Electrode: Pacing Impedance
timeFrame: 12-Month
measure: Summarize All Adverse Events
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Davenport
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Raleigh
country: United States
state: North Carolina
city: Mayfield Heights
country: United States
state: Ohio
city: Wynnewood
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
Study officials:
affiliation: St. Luke's Mid America Heart Institute, Kansas City MO
name: Brian Ramza, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: