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Attain Model 4196 Left Ventricular (LV) Lead

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271544
First Posted: January 2, 2006
Last Update Posted: September 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
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 Intervention
Heart Failure Device: Pacing Lead

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attain Model 4196 Left Ventricular (LV) Lead

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Safety (Subjects Without a Model 4196 Lead Related Complication) [ Time Frame: One Month ]
  • Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) [ Time Frame: One Month ]
  • Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) [ Time Frame: Three Months ]

Secondary Outcome Measures:
  • Subjects Successfully Implanted With Model 4196 Lead [ Time Frame: Implant ]
  • Subjects Successfully Implanted After Cannulation [ Time Frame: Implant ]
  • All Left Ventricular Leads [ Time Frame: Implant ]
  • All Medtronic Left Ventricular Leads (Attain Family) [ Time Frame: Implant ]
  • Cannulation Time [ Time Frame: Implant ]
  • Fluoroscopy Time [ Time Frame: Implant ]
  • Model 4196 Lead Placement Time [ Time Frame: Implant ]
  • Total Implant Time [ Time Frame: Implant ]
  • Assessment of Lead Handling Characteristics [ Time Frame: Implant ]
  • Electrical Performance - Tip Electrode: Sensing [ Time Frame: 12-month ]
  • Electrical Performance - Tip Electrode: LV Voltage Threshold [ Time Frame: 12-month ]
  • Electrical Performance -Tip Electrode: Pacing Impedance [ Time Frame: 12-month ]
  • Electrical Performance -Ring Electrode: Sensing [ Time Frame: Implant ]
  • Electrical Performance - Ring Electrode: LV Voltage Threshold [ Time Frame: 12-month ]
  • Electrical Performance -Ring Electrode: Pacing Impedance [ Time Frame: 12-Month ]
  • Summarize All Adverse Events [ Time Frame: Up to 18 months ]

Enrollment: 190
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4196 Lead
Non-randomized study.
Device: Pacing Lead
implant and follow-up of study device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
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


  Show 24 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: Brian Ramza, MD, PHD St. Luke's Mid America Heart Institute, Kansas City MO
  More Information

Responsible Party: 4196 Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00271544     History of Changes
Other Study ID Numbers: 241
First Submitted: December 28, 2005
First Posted: January 2, 2006
Results First Submitted: April 30, 2009
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:
Heart Failure
Heart Diseases
Cardiovascular Diseases