Back to resultsAttain Model 4196 Left Ventricular (LV) Lead
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pacing Lead
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac pacing, left ventricular lead, cardiac resynchronization therapy
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
4196 Lead
Arm Description
Non-randomized study.
Outcomes
Primary Outcome Measures
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.
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
Secondary Outcome Measures
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.
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.
All Left Ventricular Leads
All left ventricular leads successfully implanted
All Medtronic Left Ventricular Leads (Attain Family)
All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
Cannulation Time
Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
Fluoroscopy Time
Fluoroscopy time was defined as the total time the fluoroscope was imaging.
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.
Total Implant Time
Total implant time was defined as time from initial incision to final closure.
Assessment of Lead Handling Characteristics
Lead handling characteristics assessed as "acceptable" by physicians
Electrical Performance - Tip Electrode: Sensing
Model 4196 lead tip electrode R-wave amplitude
Electrical Performance - Tip Electrode: LV Voltage Threshold
Model 4196 lead tip electrode LV voltage threshold
Electrical Performance -Tip Electrode: Pacing Impedance
Model 4196 lead tip electrode pacing impedance
Electrical Performance -Ring Electrode: Sensing
Model 4196 lead ring electrode R-wave amplitude
Electrical Performance - Ring Electrode: LV Voltage Threshold
Model 4196 lead ring electrode LV voltage threshold
Electrical Performance -Ring Electrode: Pacing Impedance
Model 4196 lead ring electrode pacing impedance
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
Full Information
NCT ID
NCT00271544
First Posted
December 28, 2005
Last Updated
September 24, 2009
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00271544
Brief Title
Attain Model 4196 Left Ventricular (LV) Lead
Official Title
Attain Model 4196 Left Ventricular (LV) Lead
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, cardiac pacing, left ventricular lead, cardiac resynchronization therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4196 Lead
Arm Type
Experimental
Arm Description
Non-randomized study.
Intervention Type
Device
Intervention Name(s)
Pacing Lead
Intervention Description
implant and follow-up of study device
Primary Outcome Measure Information:
Title
Safety (Subjects Without a Model 4196 Lead Related Complication)
Description
A subject who was free of a Model 4196 lead related complication by one month visit.
Time Frame
One Month
Title
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
Description
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
Time Frame
One Month
Title
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
Description
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
Time Frame
Three Months
Secondary Outcome Measure Information:
Title
Subjects Successfully Implanted With Model 4196 Lead
Description
A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.
Time Frame
Implant
Title
Subjects Successfully Implanted After Cannulation
Description
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.
Time Frame
Implant
Title
All Left Ventricular Leads
Description
All left ventricular leads successfully implanted
Time Frame
Implant
Title
All Medtronic Left Ventricular Leads (Attain Family)
Description
All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
Time Frame
Implant
Title
Cannulation Time
Description
Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
Time Frame
Implant
Title
Fluoroscopy Time
Description
Fluoroscopy time was defined as the total time the fluoroscope was imaging.
Time Frame
Implant
Title
Model 4196 Lead Placement Time
Description
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.
Time Frame
Implant
Title
Total Implant Time
Description
Total implant time was defined as time from initial incision to final closure.
Time Frame
Implant
Title
Assessment of Lead Handling Characteristics
Description
Lead handling characteristics assessed as "acceptable" by physicians
Time Frame
Implant
Title
Electrical Performance - Tip Electrode: Sensing
Description
Model 4196 lead tip electrode R-wave amplitude
Time Frame
12-month
Title
Electrical Performance - Tip Electrode: LV Voltage Threshold
Description
Model 4196 lead tip electrode LV voltage threshold
Time Frame
12-month
Title
Electrical Performance -Tip Electrode: Pacing Impedance
Description
Model 4196 lead tip electrode pacing impedance
Time Frame
12-month
Title
Electrical Performance -Ring Electrode: Sensing
Description
Model 4196 lead ring electrode R-wave amplitude
Time Frame
Implant
Title
Electrical Performance - Ring Electrode: LV Voltage Threshold
Description
Model 4196 lead ring electrode LV voltage threshold
Time Frame
12-month
Title
Electrical Performance -Ring Electrode: Pacing Impedance
Description
Model 4196 lead ring electrode pacing impedance
Time Frame
12-Month
Title
Summarize All Adverse Events
Description
All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
Time Frame
Up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Ramza, MD, PHD
Organizational Affiliation
St. Luke's Mid America Heart Institute, Kansas City MO
Official's Role
Principal Investigator
Facility Information:
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Anchorage
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Phoenix
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Long Beach
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Lexington
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Ontario
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Montreal
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Quebec
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Canada
City
Sainte-Foy
State/Province
Quebec
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Canada
12. IPD Sharing Statement
Learn more about this trial
Attain Model 4196 Left Ventricular (LV) Lead
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