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OpenTrials
Completed

NCT Number: NCT00271544

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pacing Lead

Device

implant and follow-up of study device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jan 2, 2006
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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