Clinical trial NCT01365234: Model 20066 Left Ventricular (LV) Lead Study
Official title: Model 20066 Left Ventricular (LV) Lead Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).


Eligibility criteria: Inclusion Criteria:

* Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
* Patient has signed and dated the study-specific informed consent form
* Patient is 18 years of age or older
* Patient is expected to remain available for follow-ups at the investigational center
* Patient is willing and able to comply with protocol

Exclusion Criteria:

* Patient has a previous complete atrial based biventricular CRT system
* Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
* Patient has known coronary venous vasculature that is inadequate for lead placement
* Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
* Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Patient has chronic (permanent) atrial arrhythmias
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Patient has a terminal illness and is not expected to survive more than three months
* Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
* Patient is unable to tolerate an urgent thoracotomy

Primary outcomes:
measure: Number of implant procedure related and lead-related complications in the first month post-implant
timeFrame: One Month
Secondary outcomes:
measure: Success rate of the Model 20066 lead
timeFrame: Within 24 hours of procedure initiation
measure: Cannulation time
timeFrame: Within 24 hours of procedure initiation
measure: Fluoroscopy Time
timeFrame: Within 24 hours of procedure initiation
measure: Model 20066 Lead Placement Time
timeFrame: Within 24 hours of procedure initiation
measure: Total Implant Time
timeFrame: Within 24 hours of procedure initiation
measure: Assessment of Lead Handling Characteristics
timeFrame: Within 24 hours of procedure initiation
measure: Electrical Performance-Tip Electrode: LV Voltage Threshold
timeFrame: 12-month
measure: Electrical Performance -Tip Electrode: Sensing
timeFrame: 12-month
measure: Electrical Performance -Tip Electrode: Pacing Impedance
timeFrame: 12-month
measure: Electrical Performance -Ring Electrode: LV Voltage Threshold
timeFrame: 12-month
measure: Electrical Performance -Ring Electrode: Sensing
timeFrame: Within 24 hours of procedure initiation
measure: Electrical Performance -Ring Electrode: Pacing Impedance
timeFrame: 12-month
measure: Summarize All Adverse Events
timeFrame: 12-month
measure: Summarize Final 20066 Lead Position
timeFrame: Within 24 hours of procedure initiation
Other outcomes:
Locations:
city: London
country: Canada
city: Newmarket
country: Canada
city: Kuala Lumpur
country: Malaysia
city: Stockholm
country: Sweden
Study officials:
affiliation: London Health Sciences Centre, London, Ontario, Canada
name: Raymond Yee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7):1150-5. doi: 10.1016/j.hrthm.2014.04.020. Epub 2014 May 4.