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Attain Model 4196 Left Ventricular (LV) Lead

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ClinicalTrials.gov Identifier: NCT00271544
Recruitment Status : Completed
First Posted : January 2, 2006
Results First Posted : August 25, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: Pacing Lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attain Model 4196 Left Ventricular (LV) Lead
Study Start Date : February 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Safety (Subjects Without a Model 4196 Lead Related Complication) [ Time Frame: One Month ]
    A subject who was free of a Model 4196 lead related complication by one month visit.

  2. Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) [ Time Frame: One Month ]
    Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])

  3. Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) [ Time Frame: Three Months ]
    Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])


Secondary Outcome Measures :
  1. Subjects Successfully Implanted With Model 4196 Lead [ Time Frame: Implant ]
    A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.

  2. Subjects Successfully Implanted After Cannulation [ Time Frame: Implant ]
    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.

  3. All Left Ventricular Leads [ Time Frame: Implant ]
    All left ventricular leads successfully implanted

  4. All Medtronic Left Ventricular Leads (Attain Family) [ Time Frame: Implant ]
    All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted

  5. Cannulation Time [ Time Frame: Implant ]
    Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.

  6. Fluoroscopy Time [ Time Frame: Implant ]
    Fluoroscopy time was defined as the total time the fluoroscope was imaging.

  7. Model 4196 Lead Placement Time [ Time Frame: Implant ]
    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.

  8. Total Implant Time [ Time Frame: Implant ]
    Total implant time was defined as time from initial incision to final closure.

  9. Assessment of Lead Handling Characteristics [ Time Frame: Implant ]
    Lead handling characteristics assessed as "acceptable" by physicians

  10. Electrical Performance - Tip Electrode: Sensing [ Time Frame: 12-month ]
    Model 4196 lead tip electrode R-wave amplitude

  11. Electrical Performance - Tip Electrode: LV Voltage Threshold [ Time Frame: 12-month ]
    Model 4196 lead tip electrode LV voltage threshold

  12. Electrical Performance -Tip Electrode: Pacing Impedance [ Time Frame: 12-month ]
    Model 4196 lead tip electrode pacing impedance

  13. Electrical Performance -Ring Electrode: Sensing [ Time Frame: Implant ]
    Model 4196 lead ring electrode R-wave amplitude

  14. Electrical Performance - Ring Electrode: LV Voltage Threshold [ Time Frame: 12-month ]
    Model 4196 lead ring electrode LV voltage threshold

  15. Electrical Performance -Ring Electrode: Pacing Impedance [ Time Frame: 12-Month ]
    Model 4196 lead ring electrode pacing impedance

  16. Summarize All Adverse Events [ Time Frame: Up to 18 months ]
    All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271544


Locations
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United States, Alaska
Anchorage, Alaska, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Long Beach, California, United States
Palo Alto, California, United States
United States, Iowa
Davenport, Iowa, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Mayfield Heights, Ohio, United States
United States, Pennsylvania
Wynnewood, Pennsylvania, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, Tennessee
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Fort Worth, Texas, United States
United States, Vermont
Burlington, Vermont, United States
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Brian Ramza, MD, PHD St. Luke's Mid America Heart Institute, Kansas City MO
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Responsible Party: 4196 Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00271544    
Other Study ID Numbers: 241
First Posted: January 2, 2006    Key Record Dates
Results First Posted: August 25, 2009
Last Update Posted: September 28, 2009
Last Verified: September 2009
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
heart failure
cardiac pacing
left ventricular lead
cardiac resynchronization therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases