Attain Model 4196 Left Ventricular (LV) Lead

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Pacing Lead

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
    • Edmonton, Alberta, Canada
  • Ontario
    • Toronto, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Sainte-Foy, Quebec, Canada
• United States
  • Alaska
    • Anchorage, Alaska, United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Long Beach, California, United States
    • Palo Alto, California, United States
  • Iowa
    • Davenport, Iowa, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Michigan
    • Detroit, Michigan, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Missouri
    • Kansas City, Missouri, United States
  • North Carolina
    • Raleigh, North Carolina, United States
  • Ohio
    • Mayfield Heights, Ohio, United States
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States
  • South Carolina
    • Spartanburg, South Carolina, United States
  • Tennessee
    • Kingsport, Tennessee, United States
    • Memphis, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Fort Worth, Texas, United States
  • Vermont
    • Burlington, Vermont, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4196 Lead; Non-randomized study.	Device: Pacing Lead; implant and follow-up of study device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Subjects Without a Model 4196 Lead Related Complication)	A subject who was free of a Model 4196 lead related complication by one month visit.	One Month
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)	Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])	One Month
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)	Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])	Three Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Successfully Implanted With Model 4196 Lead	A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.	Implant
Subjects Successfully Implanted After Cannulation	A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.	Implant
All Left Ventricular Leads	All left ventricular leads successfully implanted	Implant
All Medtronic Left Ventricular Leads (Attain Family)	All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted	Implant
Cannulation Time	Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.	Implant
Fluoroscopy Time	Fluoroscopy time was defined as the total time the fluoroscope was imaging.	Implant
Model 4196 Lead Placement Time	Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.	Implant
Total Implant Time	Total implant time was defined as time from initial incision to final closure.	Implant
Assessment of Lead Handling Characteristics	Lead handling characteristics assessed as "acceptable" by physicians	Implant
Electrical Performance - Tip Electrode: Sensing	Model 4196 lead tip electrode R-wave amplitude	12-month
Electrical Performance - Tip Electrode: LV Voltage Threshold	Model 4196 lead tip electrode LV voltage threshold	12-month
Electrical Performance -Tip Electrode: Pacing Impedance	Model 4196 lead tip electrode pacing impedance	12-month
Electrical Performance -Ring Electrode: Sensing	Model 4196 lead ring electrode R-wave amplitude	Implant
Electrical Performance - Ring Electrode: LV Voltage Threshold	Model 4196 lead ring electrode LV voltage threshold	12-month
Electrical Performance -Ring Electrode: Pacing Impedance	Model 4196 lead ring electrode pacing impedance	12-Month
Summarize All Adverse Events	All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu	Up to 18 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Brian Ramza, MD, PHD, St. Luke's Mid America Heart Institute, Kansas City MO

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 28, 2005
• First Submitted That Met QC Criteria: December 30, 2005
• First Posted (Estimate): January 2, 2006

Study Record Updates

• Last Update Posted (Estimate): September 28, 2009
• Last Update Submitted That Met QC Criteria: September 24, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; heart failure; left ventricular lead; cardiac pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 241 (Registry Identifier: University Clinical Research Ethics Committee (Turkey))