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 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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Implant and follow up of Model 20066 lead
Unnamed facility
London, Canada
Unnamed facility
Newmarket, Canada
Unnamed facility
Kuala Lumpur, Malaysia
Unnamed facility
Stockholm, Sweden
Number of implant procedure related and lead-related complications in the first month post-implant
Time frame: One Month
Success rate of the Model 20066 lead
Time frame: Within 24 hours of procedure initiation
Cannulation time
Time frame: Within 24 hours of procedure initiation
Fluoroscopy Time
Time frame: Within 24 hours of procedure initiation
Model 20066 Lead Placement Time
Time frame: Within 24 hours of procedure initiation
Total Implant Time
Time frame: Within 24 hours of procedure initiation
Assessment of Lead Handling Characteristics
Time frame: Within 24 hours of procedure initiation
Electrical Performance-Tip Electrode: LV Voltage Threshold
Time frame: 12-month
Electrical Performance -Tip Electrode: Sensing
Time frame: 12-month
Electrical Performance -Tip Electrode: Pacing Impedance
Time frame: 12-month
Electrical Performance -Ring Electrode: LV Voltage Threshold
Time frame: 12-month
Electrical Performance -Ring Electrode: Sensing
Time frame: Within 24 hours of procedure initiation
Electrical Performance -Ring Electrode: Pacing Impedance
Time frame: 12-month
Summarize All Adverse Events
Time frame: 12-month
Summarize Final 20066 Lead Position
Time frame: Within 24 hours of procedure initiation
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