Attain Model 4196 Left Ventricular (LV) Lead

NCT ID: NCT00271544

Last Updated: 2009-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-12-31

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).

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4196 Lead

Non-randomized study.

Group Type: EXPERIMENTAL

Pacing Lead

Intervention Type: DEVICE

implant and follow-up of study device

Interventions

Pacing Lead

implant and follow-up of study device

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Medtronic, Inc.

Principal Investigators

Brian Ramza, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Mid America Heart Institute, Kansas City MO

Locations

Anchorage, Alaska, United States

Phoenix, Arizona, United States

Long Beach, California, United States

Palo Alto, California, United States

Davenport, Iowa, United States

Lexington, Kentucky, United States

Baton Rouge, Louisiana, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Kansas City, Missouri, United States

Raleigh, North Carolina, United States

Mayfield Heights, Ohio, United States

Wynnewood, Pennsylvania, United States

Spartanburg, South Carolina, United States

Kingsport, Tennessee, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Burlington, Vermont, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Countries

United States; Canada

Other Identifiers

241

Identifier Type: -

Identifier Source: org_study_id