Clinical trial NCT00269230: Attain StarFix™ Model 4195 Left Ventricular Lead
Official title: Attain StarFix™ Model 4195 Left Ventricular Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: cardiac resynchronization therapy, left ventricular Lead, Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 441
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: People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied.

The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.


Eligibility criteria: Inclusion Criteria:

* QRS \> 130 ms (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) \< 35% (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 and Efficacy at 3 months
timeFrame: 3 Months
Secondary outcomes:
measure: Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study
timeFrame: Ongoing
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Grand Rapids
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: St. Paul
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
city: Milano
country: Italy
Study officials:
affiliation: St. Paul Heart Clinic
name: Stuart W Adler II, MD
role: PRINCIPAL_INVESTIGATOR
References: