Attain Model 4196 Left Ventricular (LV) Lead - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Attain Model 4196 Left Ventricular (LV) Lead

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Safety (Subjects Without a Model 4196 Lead Related Complication) [ Time Frame: One Month ] [ Designated as safety issue: No ]
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) [ Time Frame: One Month ] [ Designated as safety issue: No ]
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) [ Time Frame: Three Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjects Successfully Implanted With Model 4196 Lead [ Time Frame: Implant ] [ Designated as safety issue: No ]
Subjects Successfully Implanted After Cannulation [ Time Frame: Implant ] [ Designated as safety issue: No ]
All Left Ventricular Leads [ Time Frame: Implant ] [ Designated as safety issue: No ]
All Medtronic Left Ventricular Leads (Attain Family) [ Time Frame: Implant ] [ Designated as safety issue: No ]
Cannulation Time [ Time Frame: Implant ] [ Designated as safety issue: No ]
Fluoroscopy Time [ Time Frame: Implant ] [ Designated as safety issue: No ]
Model 4196 Lead Placement Time [ Time Frame: Implant ] [ Designated as safety issue: No ]
Total Implant Time [ Time Frame: Implant ] [ Designated as safety issue: No ]
Assessment of Lead Handling Characteristics [ Time Frame: Implant ] [ Designated as safety issue: No ]
Electrical Performance - Tip Electrode: Sensing [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance - Tip Electrode: LV Voltage Threshold [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Tip Electrode: Pacing Impedance [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Ring Electrode: Sensing [ Time Frame: Implant ] [ Designated as safety issue: No ]
Electrical Performance - Ring Electrode: LV Voltage Threshold [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Electrical Performance -Ring Electrode: Pacing Impedance [ Time Frame: 12-Month ] [ Designated as safety issue: No ]
Summarize All Adverse Events [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271544

Show 24 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Principal Investigator:

Brian Ramza, MD, PHD

St. Luke's Mid America Heart Institute, Kansas City MO

More Information

No publications provided

Responsible Party:	4196 Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier:	NCT00271544 History of Changes
Other Study ID Numbers:	241
Study First Received:	December 28, 2005
Results First Received:	April 30, 2009
Last Updated:	September 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

heart failure
cardiac pacing
left ventricular lead
cardiac resynchronization therapy

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013